NCT06596915RecruitingPhase 1
Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of BA1302 in Patients With Advanced Solid Malignancies
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 167 (estimated)
- First submitted
- 11 Sept 2024
- Start date
- 11 Sept 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Shandong Boan Biotechnology Co., Ltd
- Diseases
- Melanoma, Lung cancer, Pancreatic cancer
- NCT number
- NCT06596915
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 167
- From 11 Sept 2024 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 3.History of severe hypersensitivity reactions to any ingredient of study drugs.
- 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.
Other
- 4.Pregnant or lactating women.
Who the study is looking for
- 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.
- Part A: Advanced malignant solid tumors;
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.