Clinical trial NCT06596915: Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of BA1302 in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Pancreatic Adenocarcinoma
Breast Cancer
Melanoma
Lead sponsor: Shandong Boan Biotechnology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a first-in-human (FIH), multicenter, open-label Phase I study to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary efficacy of BA1302 in patients with advanced solid malignancies. The study includes a dose-escalation phase (Part A) and a dose-expansion phase (Part B).


Eligibility criteria: Inclusion Criteria:

* 1. Metastatic or unresectable solid malignancy that is histologically or cytologically confirmed. Patients who have progressed on or after standard therapy, or are intolerant of standard therapy, or have no appropriate standard therapy available.

  1. Part A: Advanced malignant solid tumors;
  2. Part B: Metastatic melanoma, Advanced breast cancer, Advanced Non-small cell lung cancer (NSCLC), Advanced pancreatic adenocarcinoma.
* 2.Participants should be able to provide adequate tumor tissue for biomarker analysis
* 3.ECOG Performance Status ≤ 1.
* 4.Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)

Exclusion Criteria:

* 1. Malignant disease within 5 years prior to the first dose of investigational drug other than that being treated in this study. Except completely resected basal cell carcinoma, cutaneous squamous cell skin carcinoma and papillary thyroid carcinoma and completely resected carcinoma in situ of any type.
* 2. Received any chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, ADC medication or other anti-cancer treatment within 28 days prior to the first dose.
* 3.History of severe hypersensitivity reactions to any ingredient of study drugs.
* 4.Pregnant or lactating women.
* 5.Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.

Primary outcomes:
measure: Number of participants with dose limiting toxicities
timeFrame: Up to 21 days
measure: adverse events
timeFrame: Through 28 days after the last study treatment
Secondary outcomes:
measure: Area under the concentration-time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t)
timeFrame: Up to approximately 1 years
measure: AUC from time zero to infinity (AUC0-inf)
timeFrame: Up to approximately 1 years
measure: Maximum serum concentration (Cmax)
timeFrame: Up to approximately 1 years
measure: Elimination half-life (t1/2)
timeFrame: Up to approximately 1 years
measure: Area under the concentration-time curve (AUC) at steady state
timeFrame: Up to approximately 1 years
measure: Incidence of anti-drug antibodies (ADA)
timeFrame: Up to approximately 1 years
measure: Objective response rate (ORR)
timeFrame: Up to approximately 1 years
measure: Duration of objective response (DOR)
timeFrame: Up to approximately 1 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
References: