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Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

ConditionsNon-Small Cell Lung CancerPancreatic AdenocarcinomaBreast CancerMelanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShandong Boan Biotechnology Co., Ltd

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • BA1302

    Drug

    BA1302 administered intravenously

Treatment groups

167 Participants
are divided into 1 treatment group
Group A: BA1302Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with dose limiting toxicities

Time frame
Up to 21 days
2

adverse events

Time frame
Through 28 days after the last study treatment

Secondary outcomes

1

Area under the concentration-time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t)

Time frame
Up to approximately 1 years
2

AUC from time zero to infinity (AUC0-inf)

Time frame
Up to approximately 1 years
3

Maximum serum concentration (Cmax)

Time frame
Up to approximately 1 years
4

Elimination half-life (t1/2)

Time frame
Up to approximately 1 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Boan Biotechnology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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