A Multicenter, Open-Label, Phase Ia/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-C0979 in Patients With Selected Advanced Solid Tumors
Study Identifier:
BG-C0979-101
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid tumors. The study will consist of Phase 1a (Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).
This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy in selected patients with advanced solid tumors. The study will include Phase 1a (dose escalation and safety extension) and Phase 1b (dose extension). Under this approval, only monotherapy studies will be conducted in China.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Non-Small Cell Lung Cancer
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- * Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
- * Phase 1b Part A (Monotherapy Dose Optimization and Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
- * Phase 1b Part B (Combination Therapy Expansion): Participants with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors who have not received any prior systemic treatment for advanced or metastatic disease.
- * Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
- * Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- * Participants must have adequate organ function.
Exclusion criteria
- Prior treatment with any ADAM9 (a disintegrin and metalloproteinase domain 9)-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 (DNA topoisomerase 1) inhibitor as payload.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- 1Previously received any ADAM9-targeting ADC or ADC therapy with a TOPO1 inhibitor as the payload.2Having active leptomeningeal disease or poorly controlled and untreated brain metastases.3Patients with a history of ILD or grade 2 or higher non-infectious pneumonia within ≤ 2 years prior to enrollment, or currently suffering from ILD/non-infectious pneumonia, or whose suspected active ILD/non-infectious pneumonia could not be ruled out by imaging examinations during the screening period.4During the screening period, the resting blood oxygen saturation was <92%.5There is poorly controlled pleural effusion, pericardial effusion or ascites that requires frequent drainage (recurrence within 14 days after intervention).6The presence of underlying medical conditions (including abnormal laboratory test results) that are detrimental to the administration of the study drug, affect the interpretation of drug toxicity or adverse events, or lead to insufficient/reduced compliance with study requirements, or alcohol or drug abuse/dependency.7Patients must have had a clinically significant infection (including tuberculosis) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral treatment within 14 days prior to enrollment. Patients receiving prophylactic antibiotic treatment (e.g., for urinary tract infections, chronic obstructive pulmonary disease, or post-extraction infections) are eligible for enrollment.8Patients must have undergone any major surgery within ≤ 28 days prior to enrollment. If the time between surgery and enrollment is > 28 days, the patient must have fully recovered from the surgery and/or surgical complications before enrollment.9Exclusion criteria defined by other schemes.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Victor Moreno Garcia
Status
Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Solid Tumor