A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1203 in Advanced Solid Tumors.

NCT07876609 | Recruiting Phase 1

• 1 other identifier: BA1203/CT-CHN-101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1203 in participants with advanced solid tumors.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of adverse events (AEs), TEAEs, and SAEs, irAEs, IRRs, AESIs, and adverse events leading to dose reduction, treatment interruption, permanent discontinuation, and death (according to NCI CTCAE 6.0)

  Through 28 days after the last study treatment

• Incidence and severity of DLTs in each dose cohort, and MTD

  Through 28 days after the last study treatment

• RP2D of BA1203

  Through 28 days after the last study treatment

Study Arms (1)

BA1203

EXPERIMENTAL

Participants will receive BA1203 once every 2 weeks (Q2W), until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the maximum duration of administration was no more than 2 years.

Drug: BA1203

Interventions

BA1203 DRUG

intravenous (IV) once every 2 weeks (Q2W).

BA1203

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent and to comply with the study protocol;
• Subject with histologically or cytologically confirmed advanced and/or metastatic solid tumors who have progressed on all standard therapies, are intolerant to Standard-Of-Care (SOC), and/or are non-amenable to SOC;
• At least one measurable lesion according to RECIST v1.1;
• Patients with colorectal cancer must have a microsatellite instability (MSI) test report, and patients with other tumor types must have a prior PD-L1 histopathological examination report; if unavailable, tumor tissue specimens must be provided for the above tests.;
• Life expectancy \>=12 weeks;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Adequate major organ function;
• Women of Childbearing Potential must have a negative pregnancy test within 7 days prior to the first dose: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods;
• Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm.

You may not qualify if:

• Patients with primary CNS tumors or new or symptomatic CNS metastases.
• Patients with a known history of another malignancy within 5 years prior to signing the informed consent.
• Patients with significant cardiovascular and cerebrovascular diseases.
• Presence of any of the following within 8 weeks before the first dose: symptomatic radiation pneumonitis, radiation esophagitis, or radiation-induced colitis/proctitis; interstitial lung disease; pulmonary disease with severe obstructive ventilatory impairment; unhealed peptic ulcer; cirrhosis-related complications; chronic enteritis; ischemic necrotizing enteritis; gastrointestinal obstruction; tendency to gastrointestinal bleeding or high risk of gastrointestinal perforation; pancreatitis requiring treatment; arterial or venous thrombotic disease; chronic nephritis; or nephrotic syndrome.
• Any active autoimmune disease, or autoimmune or inflammatory disease requiring immunosuppressive therapy.
• History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug-induced hypersensitivity syndrome (DIHS).
• History of allogeneic hematopoietic stem cell transplantation or organ transplantation, or currently awaiting transplantation.
• Immune-related adverse events during prior antitumor therapy that make the patient no longer suitable for continued immunotherapy.
• Prior treatment with PD-1/IL-2 or PD-1/IL-15 agents.

Sponsors & Collaborators

• Shandong Boan Biotechnology Co., Ltd: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)