Taking people in ChinaPhase 1
Tests BA1302 in adults with advanced solid cancers
Tests the drug BA1302 in adults with advanced cancers.
Key facts
- Who runs it
- Shandong Boan Biotechnology Co., Ltd
- Where
- Beijing, ChinaSee the site
- Trial code
- Registry title
- Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 167 people, planned
- Started
- 11 Sept 2024
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional
- Treatments tested
- BA1302
- Record updated
- 13 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced solid tumors that have spread or cannot be removed by surgery, and that have worsened on or after standard treatment, cannot be treated with it, or have no standard treatment.
- Age
- 18 years or older.
- Sex
- Men and women can join.
- Disease stage
- Metastatic or unresectable solid tumor confirmed by tissue or cell tests. In the first part, any advanced solid tumor. In the second part, metastatic melanoma, advanced breast cancer, advanced non-small cell lung cancer or advanced pancreatic adenocarcinoma. The disease must be measurable by RECIST v1.1.
- Earlier treatment
- The cancer has progressed on or after standard therapy, or standard therapy was not tolerated, or no appropriate standard therapy is available. No chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, ADC medication or other anti-cancer treatment within 28 days before the first dose.
- Biomarker or test result
- Enough tumor tissue must be available for biomarker analysis.
Main reasons for not taking part
- Another cancer within 5 years before the first dose, with a few exceptions such as completely resected basal cell carcinoma
- Anti-cancer treatment within 28 days before the first dose
- Severe allergic reaction to any ingredient of the study drugs
- Pregnant or breastfeeding women
- Any condition that, in the investigator's judgment, prevents safe or reliable participation
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
- 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
- 4.Pregnant or lactating women
Where in China
- Beijing Cancer HospitalBeijing, ChinaContact: primary investigatorTaking people
About the trial
What the trial wants to find out
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).
The group in the trial
- BA1302Treatment being tested
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of BA1302 in Patients With Advanced Solid Malignancies
- Plain-language title
- Tests BA1302 in adults with advanced solid cancersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 13 October 2026