Non-Small Cell Lung CancerPhase 1NCT06596915
Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors
A Phase 1 study testing BA1302 in people with Non-Small Cell Lung Cancer and Pancreatic Adenocarcinoma, run by Shandong Boan Biotechnology Co., Ltd at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Pancreatic Adenocarcinoma, Breast Cancer
- What is being tested?
- BA1302
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2024to 31 Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of BA1302 in Patients With Advanced Solid Malignancies
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).
- Being tested
- BA1302
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BA1302Drug
BA1302 administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| BA1302 | Experimental | Not described Receives: Drug: BA1302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities
Measured: Up to 21 days
adverse events
Measured: Through 28 days after the last study treatment
Secondary outcomes (8)
Area under the concentration-time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t)
Measured: Up to approximately 1 years
AUC from time zero to infinity (AUC0-inf)
Measured: Up to approximately 1 years
Maximum serum concentration (Cmax)
Measured: Up to approximately 1 years
Elimination half-life (t1/2)
Measured: Up to approximately 1 years
Area under the concentration-time curve (AUC) at steady state
Measured: Up to approximately 1 years
Incidence of anti-drug antibodies (ADA)
Measured: Up to approximately 1 years
Objective response rate (ORR)
Measured: Up to approximately 1 years
Duration of objective response (DOR)
Measured: Up to approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start11 Sep 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Boan Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596915
- Sponsor's protocol ID
- BA1302/CT-CHN-101
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No