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  • American Society of Clinical Oncology (ASCO)  (7)
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  • American Society of Clinical Oncology (ASCO)  (7)
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  • 1
    Online Resource
    Online Resource
    Safety and tolerability of HLX07 combined with chemotherapy in patients with advanced solid tumors.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. e15001-e15001
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. e15001-e15001
    Abstract: e15001 Background: HLX07 is a novel humanized anti-EGFR monoclonal antibody. This study aimed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HLX07 combined with different chemotherapy regimens (chemo-regimens) in patients with advanced solid tumors. Methods: This was a single-center, open-label, dose-escalation phase 1b/2 study. Three fixed-dose chemo-regimens were given together with HLX07: 1) gemcitabine 1000 mg/m 2 (on Days 1 and 8) and cisplatin 75 mg/m 2 (on Day 1) in 3-week cycles for 4–6 cycles; 2) paclitaxel 80 mg/m 2 and carboplatin AUC = 2 (both on Days 1, 8, and 15) in 3-week cycles for 4–6 cycles; and 3) mFOLFOX6 (on Day 1) in 2-week cycles for 6–12 cycles. Patients with metastatic or recurrent advanced solid tumors suitable to be treated with the above chemo-regimens were given HLX07 IV at escalating doses (400, 600, or 800 mg, QW) combined with chemotherapies following BOIN design. The primary endpoints were dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD). Secondary endpoints included safety and preliminary efficacy. Results: As of August 28, 2022, 56 patients were enrolled; 21 received HLX07 with gemcitabine and cisplatin, 21 received HLX07 with paclitaxel and carboplatin (n = 3 for HLX07 400 and 600 mg, n = 15 for HLX07 800 mg for each chemo-regimen), and 14 received HLX07 with mFOLFOX6 (n = 3 for HLX07 400 and 600 mg, n = 8 for HLX07 800 mg). No DLT related to HLX07 was reported. The MTD was not reached. A summary of treatment-emergent adverse events (TEAEs) in each group is shown in Table 1. All patients experienced TEAEs. Grade ≥3 TEAEs were reported by 17 (81.0%), 20 (95.2%), and 12 (85.7%) patients in each chemo-regimen group, respectively. Only 1 (33.3%) patient in the HLX07 400 mg plus paclitaxel and carboplatin group experienced TEAE leading to death (upper gastrointestinal hemorrhage, possibly unrelated to study drugs). Conclusions: HLX07 was safe and well tolerated when combined with chemotherapy in patients with advance solid tumors. Clinical trial information: NCT03577704 . [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.e15001
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    Safety, tolerability, and preliminary pharmacokinetic/pharmacodynamic profile of JMT103 in patients with bone metastases from solid tumors: A multicenter, open-label, dose-escalation, phase I clinical study.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 3638-3638
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 3638-3638
    Abstract: 3638 Background: Bone is one of the most common metastatic sites of malignancies. The metastatic tumor cells activate osteoclast activity and promote bone resorption via RANKL/RANK signaling pathway, and lead to osteolytic destruction. JMT103 is an innovative fully human IgG4 monoclonal antibody targeting RANKL. It can block RANKL/RANK signaling pathway, inhibit bone resorption, and protect bones from tumor metastasis. This study aimed to evaluate the safety and tolerability of JMT103 in patients with bone metastasis. Methods: This is a multi-center, open label, dose escalation, phase I clinical trial. The patients (ECOG score: 0-1) with bone metastasis from solid tumor who had not received bisphosphonates within 6 weeks before enrollment and were naïve to denosumab were enrolled. The initial dose was 0.5 mg/kg, sequentially escalated to 1.0, 2.0, and 3.0 mg/kg. JMT103 was injected subcutaneously by accelerated titration in 0.5 and 1.0 mg/kg dose groups, but via traditional "3+3" dose-escalation design in 2.0 and 3.0 mg/kg dose groups. Expansion study was conducted for subjects in 1.0, 2.0, and 3.0 mg/kg dose groups. Specifically, 3 additional doses (q4w) were injected after the end of 12-week single-dose study. The primary endpoints were maximum tolerated dose and safety. The secondary outcome measures included PK profile, preliminary efficacy biomarkers, immunogenicity, and bone mineral density (BMD). Results: From May 2018 to January 2020, 56 patients (13 males, 43 females, mean (SD) age: 55.57 (11.42) years) were enrolled, including bone metastasis from breast cancer (n = 36), gastric cancer (n = 5), lung cancer (n = 4), rectal cancer (n = 3), colorectal cancer (n = 2), or other solid tumors (n = 6). Nineteen patients participated in the dose-escalating study and 37 patients participated in the expansion study. JMT103 showed overall good safety. There were 74 drug-related AEs in all, including grade 3 (DLT hypocalcemia, n = 1; hypophosphatemia, n = 3), grade 2 (n = 15), and grade 1 (n = 55) AEs. The most common drug-related AEs were hypophosphatemia (n = 15), hypocalcemia (n = 12), and hypermagnesemia (n = 6). Median uNTx/Cr decrease from baseline was 76.6% (n = 20). Conclusions: JMT103 shows good safety and tolerability in patients with bone metastasis. Clinical trial information: NCT03550508 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.3638
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 3
    Online Resource
    Online Resource
    First-in-human (FIH) phase I study of GST-HG161, a potent and highly selective c-met inhibitor, in patients with advanced solid tumor.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e16126-e16126
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e16126-e16126
    Abstract: e16126 Background: GST-HG161 is an orally bioavailable novel potent and highly selective c-Met inhibitor, which displayed significant antitumor activity in preclinical models as well as very desirable pharmaceutical properties for oral dosing. Preclinical studies demonstrated that GST-HG161 has the potential to be effective in HCC patients with active c-Met signaling. Methods: This is an open label, first-in-human, single center, dose-escalation study (NCT04228406) utilizing an accelerated dose escalation design using single patient cohorts for the first two dose levels (60 and 150 mg) followed by a conventional 3+3 design at the 3 rd dose cohort (300 mg). Dose escalation is expected to continue to the proposed 7 th dose cohort (900 mg). The objective of the study is to determine the maximum tolerated dose and/or recommended Phase II dose, dose limiting toxicities (DLT), safety, pharmacokinetics, pharmacodynamics and preliminary signals of anticancer efficacy of GST-HG161 in patients with advanced solid tumors. Eligible patients are adults with advanced solid tumors refractory to standard therapies with confirmed c-Met positive. The definition of c-Met positive is a) IHC expression of c-Met (positive criteria: 1+ and above) and/or b) FISH amplification of c-Met and/or c) MET exon 14 (METex14) skipping. GST-HG161 is administered orally once-a-day starting on day 1 of each 21 days cycle. Results: To date, 6 patients (CRC 2, Gastric 1, NSCLC 1, HCC 1, Cholangiocarcinoma 1) were enrolled to 3 dose levels (60, 150, and 300 mg). Of these 6 patients, 4 had discontinued GST-HG161 treatment at the data cut-off date of Feb 1, 2020, due to progressive disease (3) and adverse event (1). Two patients at the 300 mg cohort are still on treatment. Overall, 4/6 patients showed no drug-related AEs 〉 Grade 1. One patient reported a DLT: asymptomatic Grade 3 lipase elevation after a single dose of 60mg. To date, no other patients showed elevations of lipase and amylase. Bioanalysis of PK samples from study patients are currently ongoing. PK summary will be reported in the presentation. Conclusions: GST-HG161 has been well tolerated to date in study patients with a manageable safety profile. The dose escalation is expected to continue to the proposed 7 th cohort at 900 mg. Clinical trial information: NCT04228406 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e16126
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 4
    Online Resource
    Online Resource
    First-in-human phase I study of anti-HER2 ADC MRG002 in patients with relapsed/refractory solid tumors.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. TPS1101-TPS1101
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. TPS1101-TPS1101
    Abstract: TPS1101 Background: MRG002 is an antibody drug conjugate (ADC) composed of a humanized anti-HER2 IgG1 monoclonal antibody conjugated to a microtubule disrupting agent monomethyl auristatin E (MMAE). MRG002 is presently being investigated in an ongoing phase I study for safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity in patients (pts) with solid tumors. Methods: MRG002 is evaluated as monotherapy for the treatment of pts with confirmed HER2 positive locally advanced or metastatic cancers, including breast cancer (BC), gastric cancer (GC), salivary gland cancer (SGC) and others. The primary objective is to determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D). Secondary objectives include evaluation of PK, tumor response, and immunogenicity. In the dose escalation phase with “3+3” design, approximately 24 pts will be enrolled to identify MTD. The starting dose of MRG002 is 0.3 mg/kg, followed by 0.6, 1.2, 1.8, 2.2, 2.6, and 3.0 mg/kg. In the dose expansion phase, about 50 pts with HER2 positive advanced cancers will be enrolled to further evaluate the safety, antitumor activity, and PK at an appropriate confirmed dose. In this phase I study, each pt receives single agent MRG002 once every 3 weeks (Q3W) for a maximum of 8 treatment cycles. Pts with BC and GC should have HER2 positive advanced solid tumors per College of American Pathologists (CAP) guidelines. For other cancers, pts must have IHC status of 2+ or 3+, regardless of FISH results. Pts should have either failed or are ineligible for standard treatments. All pts must have at least 1 measurable lesion per RECIST 1.1. ECOG should be 0-1, and bone marrow, hepatic, renal, cardiac functions should be adequate. Observations include adverse events (AEs), dose-limiting toxicity (DLT), and antitumor activity, which is assessed every two treatment cycles. Further clinical trial details can be found on chinadrugtrials.org.cn (CTR20181778). Enrollment is ongoing since November 2018. Clinical trial information: CTR20181778 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.TPS1101
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 5
    Online Resource
    Online Resource
    WX390, a high-potent PI3K-mTOR dual inhibitor, first-in-human (FIH) phase I study in advanced relapsed or refractory solid tumor, and lymphoma.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 3106-3106
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 3106-3106
    Abstract: 3106 Background: WX390 is a high potent PI3K-mTOR dual inhibitor targeting pan-PI3K and mTOR. WX390 exhibited anti-tumor activity and high potency in xenograft models with inhibition of AKT phosphorylation. Methods: Patients (pts) with advanced lymphoma and solid tumors who have failed standard therapies were enrolled in dose escalation cohorts and received WX390 administered daily orally in 28-day cycles until confirmed progressive disease, intolerable toxicity or withdrawal of consent. Plasma samples were collected up to 7 days after the first dose and up to 24 hours at C1D28. Results: As of the cut-off date 2021 Feb 10, 25 patients (median age 52 years) were enrolled in 6 dose levels (0.1mg, 0.2mg, 0.4mg, 0.7mg, 1.1mg and 1.4mg) of the dose-escalation cohorts. Cohorts 0.1 mg to 1.1 mg were completed without dose-limiting toxicities (DLT), cohort 1.4 mg was completed with 1 DLT (Diabetic ketoacidosis combined with grade 3 hyperglycemia) out of 4 evaluable patients. Common treatment-related adverse events (TRAEs) (all grades, ≥20%) included hyperglycemia (20 pts, 80%), proteinuria (10 pts, 40%), creatinine increased (11 pts, 44%), hypophosphatemia (10 pts, 25%), anemia (8 pts, 33.3%), thrombocytopenia (7 pts, 29.2%), and aspartate aminotransferase increased (25%). Grade≥3 TRAEs were hyperglycemia (7 pts, 28%, 1 pt combined with diabetic ketoacidosis), hypophosphatemia (2 pts, 8%), neutropenia (2 pts, 8%), dermatitis (1 pt, 4%), and maculopapular rash (1 pt, 4%). PK showed fast absorption (Tmax 0.5-4 h) and dose proportionality for Cmax and AUC 0-∞ . The mean multiple dose T 1/2 was approximately 12.4 hours across all cohorts with minimum accumulation. Among 14 tumor response evaluable patients, there were 3 patients with confirmed PIK3CA mutation. All 3 patients experienced tumor shrinkage and were still on treatment by the cut-off date. 2 (1 pt with head and neck cancer and 1 pt with cervical cancer) of them have achieved partial response (PR). The head and neck cancer patient (PR) was treated with WX390 0.7mg/day without any severe AE and the duration of response was beyond 15 months. Stable disease (SD) was observed in 6 patients (n = 5 with unknown PIK3CA mutation status and n = 1 with confirmed PIK3CA mutation). Of note, 1 patient (follicular lymphoma) treated with 0.1mg experienced SD for 14 months. Another patient (SD, head and neck cancer with PIK3CA mutation) experienced tumor shrinkage for more than 8 months and was still receiving WX390 treatment by the cut-off date. Conclusions: the PI3K-mTOR dual inhibitor WX390 was well tolerated with manageable safety profile, and showed encouraging antitumor activity. A RP2D of 1.1 mg qd is selected to be explored for different indications in solid tumor clinical studies. Clinical trial information: NCT03730142.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.3106
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 6
    Online Resource
    Online Resource
    PIONEER: A multicenter, open-label, randomized phase II trial of second-line apatinib plus chemotherapy versus chemotherapy alone in gastric and gastroesophageal junction adenocarcinoma (GA/GEA) refractory to or intolerant of prior anti-PD-1 therapy.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 4_suppl ( 2022-02-01), p. TPS361-TPS361
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 4_suppl ( 2022-02-01), p. TPS361-TPS361
    Abstract: TPS361 Background: Immunotherapy has revolutionized landscape of cancer treatment. Anti-PD-1 therapy provides significant clinical benefit and durable response in various types of cancers. However, clinical response rate to anti-PD-1 therapy has been reported to vary from 10%-40% in different cancers. And, a substantial number of patients who initially responded to anti-PD-1 therapy developed acquired resistance over time. Few effective treatment options are available for such patients. Previous studies indicated that prior anti-PD-1 exposure might increase tumor response to anti-VEGFR2 (ramucirumab) plus chemotherapy in patients with advanced/metastatic GA/GEA. Apatinib, a highly selective VEGFR2 inhibitor, has been demonstrated to be efficacious and well-tolerated for the treatment of chemotherapy-refractory advanced GA/GEA. The PIONEER study is designed to evaluate the efficacy and safety of second-line apatinib plus chemotherapy in GA/GEA patients after prior anti-PD-1 therapy. Methods: PIONEER (NCT05029453) is a multicenter, open label, randomized phase II trial of second-line apatinib plus chemotherapy versus chemotherapy alone in patients with histologically confirmed advanced GA/GEA refractory to or intolerant of prior anti-PD-1 therapy for no less than 2 months. Patients must be ≥18 years of age, with ECOG PS of 0 or 1, and have measurable disease per RECIST v1.1, adequate organ function, and expected survival time of ≥12 weeks. Patients who previously received antiangiogenic agents (such as apatinib or ramucirumab), had concurrent or previous tumor history within past 3 years, or underwent anti-tumor therapy within 4-week of recruitment will be excluded. Approximately 60 patients will be randomized (1:1) to receive apatinib (500 mg orally qd) plus chemotherapy (docetaxel 60/75 mg/m 2 , d1 q3w, and nab-paclitaxel 125 mg/m 2 d1 & d8 q3w or 260 mg/m 2 d1 q3w) or chemotherapy alone until disease progression, unacceptable toxicity, or death. The primary endpoint is progression-free survival (PFS). The secondary endpoints are overall response rate (ORR), disease control rate (DCR), duration of response (DOR), overall survival (OS), and adverse events (AEs) per NCI CTCAE v5.0. Patient enrollment has just started and is expected to be completed in June 2022. Clinical trial information: NCT05029453.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.4_suppl.TPS361
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 7
    Online Resource
    Online Resource
    A phase Ib trial of the VEGF fusion protein HB002.1T plus chemotherapy in patients with advanced solid tumors.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 2530-2530
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 2530-2530
    Abstract: 2530 Background: HB002.1T is a recombinant human vascular endothelial growth factor receptor (VEGF)-IgG Fc fusion protein, which functions as a decoy receptor to bind VEGF-A, VEGF-B and placental growth factor (PlGF). In phase Ia, HB002.1T monotherapy showed encouraging anti-tumor activity in gallbladder cancer. Methods: This study aimed to evaluate efficacy and safety of HB002.1T plus chemotherapy (mainly based on platinum, paclitaxel, gemcitabine, etc.) in advanced solid tumors. The tumor assessment was evaluated by investigator according to RECIST v1.1. The study included part 1 and part 2, part 1 study was dose escalation (12mg/kg, 16mg/kg Q3W) and dose expansion conducted in patients (pts) with advanced solid tumors, part 2 study was dose expansion (16mg/kgQ3W) in specified tumors (cohort 1: ovarian and cervical, cohort 2: pancreatic, gallbladder and bile duct cancer). Results: As of Dec 20,2022,68 (42F/26M) advanced solid tumor pts were enrolled in the study with 32 pts in part 1 and 36 pts in part 2. 33.3% pts failed at least 3 lines of therapy before enrollment. 63(92.6%) pts had stage IV disease. Median age was 58. It is to be note that 12 efficacy assessment evaluablepts with ovarian cancer (1 with 12mg/kg in part 1,11with 16mg/kg in part 2) were all stage IV, which included 3 complete response (CR),6 partial responses (PR) and 3 stable disease (SD). Median progression free survival (PFS) was 7.3 months and 6-month PFS rate was 58.3%. The ORR and DCR were 75%, 100% respectively. The most common treatment related adverse events (TRAEs) included neutropenia (9/12, 75.0%) and leukocytopenia (8/12, 66.7%). 8 (8/12, 66.7%) pts had grade ≥ 3 TRAEs, which neutropenia (4/12, 33.3%) and leukocytopenia (3/12, 25.0%) were commonly observed. Part 1: In 28 pts whose tumor assessment were available, including 1 gastric cancer patient achieved CR, 11 pts achieved PR (2 gastric, 2 ovarian, 2 cervical, 1 maxillary, 1 lung, 1 parotid, 1 nasopharynx, 1 pancreatic) and 15 achieved SD. Part 2: 32 pts were available for tumor assessment, including 4 achieved CR (3 ovarian, 1 cervical), 10 achieved PR (4 ovarian, 2 cervical, 3 bileduct, 1 pancreatic), and 16 achieved SD. Overall, in Part 1 and 2, TRAEs occurred in 64 (64/68, 94.1%) pts. The most common TRAEs were leukocytopenia (28/68, 41.2%), neutropenia (26/68, 38.2%) and proteinuria (25/68, 36.8%). 34 (34/68, 50.0%) pts had grade ≥ 3 TRAEs, which neutropenia (15/68, 22.1%) and leukocytopenia (11/68, 16.2%) were commonly observed. TRAE leading to discontinuation occurred in 3 pts. No death was reported related with HB002.1T. Conclusions: The Pts were well tolerated to 12mg/kg and 16mg/kg HB002.1T dose combined with chemotherapy, and HB002.1T showed acceptable safety profile. As well as, promising anti-tumor activity was observed in various tumors, especially in advanced ovarian cancer. More data is being accumulated, and confirmatory clinical trials are being prepared. Clinical trial information: NCT04802980 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.2530
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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