Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This study consists of a dose-escalation and expansion stage (Phase 1) to determine the recommended Phase 2 dose (RP2D), and an extension stage (Phase 2) where participants will be enrolled into specific cohorts based on their diagnosis. Participants will receive GB263T via intravenous infusion (IV) at increasing dose levels until the maximum tolerated dose is reached, or all planned doses are administered. Participants will receive GB263T at predefined dose levels and frequency, based on observed safety and protocol defined criteria. The duration of each treatment cycle is 28 days.
Conditions
This trial is treating people with advanced solid cancers, including non-small lung cancer
Eligibility
Inclusion
- ≥18 years of age.
- Subjects with histologically or cytologically confirmed metastatic or unresectable advanced NSCLC or other solid tumors who have progressed on prior standard therapy, have been intolerant to prior standard therapy, or have refused all other currently available therapeutic options.
- Subjects must have evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- ECOG PS 0-1.
- An expected survival time is ≥3 months.
- Adequate organ function.
- Subjects in Phase II must agree to provide pre-treatment tumor tissue samples.
Exclusion
- Subjects who have had prior chemotherapy, targeted cancer therapy, immunotherapy, or any investigational anti-cancer treatment within 2 weeks or five half-lives of the treatment (whichever is longer), prior to the first administration of the study drug.
- Toxicity (excluding alopecia, peripheral neuropathy, and hypothyroidism) that did not return to class 0 or class 1 of NCI CTCAE V5.0 from prior antitumor therapy prior to the first administration of the study drug.
- Prior radical radiation therapy completed within 4 weeks prior to the first administration of the study drug.
- Subjects with untreated symptomatic brain metastases.
- History of interstitial lung disease (ILD).
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- Received live virus vaccination within 30 days of first dose of study treatment.
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- Your cancer has not spread to other parts of the body (localised).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Genor Biopharma Co., Ltd.
Scientific Title
A Phase I/II, First-in-Human, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of a Trispecific EGFR/cMET/cMET Antibody GB263T in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
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