Testing GB263T for advanced lung and solid tumors

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

This study is testing a new treatment called GB263T to see if it can help people with advanced lung cancer and other solid tumors who haven't had success with standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Genor Biopharma Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 4 sites (Saint Leonards, New South Wales and 3 other locations)
• Trial ID: NCT05332574 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and preliminary activity of GB263T in patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. It consists of a dose-escalation phase to determine the recommended phase 2 dose (RP2D) followed by an expansion phase where participants are enrolled in indication-specific cohorts. The study aims to provide insights into the efficacy of GB263T for patients who have not responded to standard therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced NSCLC or other solid tumors that have progressed after standard therapies.

Not a fit: Patients who have recently undergone chemotherapy or other anti-cancer treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced NSCLC and other solid tumors who have limited treatment choices.

How similar studies have performed: Similar studies have shown promise in targeting advanced solid tumors, but the specific approach with GB263T is novel.

Eligibility criteria

Inclusion Criteria:

1. ≥18 years of age.
2. 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.
3. Subjects must have evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
4. ECOG PS 0-1.
5. An expected survival time is ≥3 months.
6. Adequate organ function.
7. Subjects in Phase II must agree to provide pre-treatment tumor tissue samples.

Exclusion Criteria:

1. 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.
2. 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.
3. Prior radical radiation therapy completed within 4 weeks prior to the first administration of the study drug.
4. Subjects with untreated symptomatic brain metastases.
5. History of interstitial lung disease (ILD).
6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
7. Received live virus vaccination within 30 days of first dose of study treatment.

Where this trial is running

Saint Leonards, New South Wales and 3 other locations

• Genesis Care — Saint Leonards, New South Wales, Australia (Recruiting)
• Westmead Hospital — Westmead, New South Wales, Australia (Recruiting)
• Cabrini Hospital Malvern — Malvern, Victoria, Australia (Recruiting)
• St Vincent's Hospital Melbourne — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Shawn Yu, MD

Conditions NSCLC; Other Solid Tumors; Phase 1/2; GB263T; EGFR/cMET/cMET