Phase 1 Study of BMS-986148

A Phase 1 Study of the Safety and Tolerability of BMS 986148 in Subjects With Advanced and/or Metastatic Solid Tumors

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223357

Enrollment

Registered

2016-10-24

Start date

2016-10-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumors

Interventions

investigational material(s) Generic name etc : BMS-986148 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational materi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subject with advanced and/or metastatic solid tumors which are expected to express mesothelin who received the previous treatment Must have measurable tumor per Response Evaluation Criteria in Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion criteria

Exclusion criteria: Cancer metastases in the brain Uncontrolled or significant cardiovascular disease Moderate eye disorders Moderate peripheral neuropathy Known past or active hepatitis B or C infection

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of BMS-986148. Adverse event and Serious adverse event	—

Secondary

Measure	Time frame
Preliminary anti-tumor activity of BMS-986148 To characterize the PK of the total antibody, active ADC and unconjugated tubulysin To characterize the immunogenicity of BMS-986148 Response Evaluation Criteria The following PK parameters of total antibody, active ADC and unconjugated tubulysin: Cmax, Tmax, AUC(0-T), AUC(TAU), Cavg, T-HALF, Ctrough, Ctau, CLT, Vss, Vz, AI_AUC, AI_Cmax and AI_Ctau Immunogenicity status	—

Measure

Time frame

Preliminary anti-tumor activity of BMS-986148 To characterize the PK of the total antibody, active ADC and unconjugated tubulysin To characterize the immunogenicity of BMS-986148 Response Evaluation Criteria The following PK parameters of total antibody, active ADC and unconjugated tubulysin: Cmax, Tmax, AUC(0-T), AUC(TAU), Cavg, T-HALF, Ctrough, Ctau, CLT, Vss, Vz, AI_AUC, AI_Cmax and AI_Ctau Immunogenicity status

—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026