Clinical trial · Interventional
Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors
A Phase Ia/Ib, Open-Label, First-in-human, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BC3195 in Patients With Locally Advanced or Metastatic Solid Tumors
NCT05957471CI-TRIAL-00068215BC3195unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug: BC3195 for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BC3195 treatment group.
- description
- BC3195 via intravenous(IV).
- interventionNames
- Drug: Drug: BC3195 for Injection
Primary outcomes (1)
- measure
- Incidence of dose limiting toxicities (DLTs) .
- timeFrame
- Dose limiting toxicities (DLT) will be assessed At the end of Cycle 1 (each cycle is 21 days).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients voluntarily participate in the study and should provide a written informed consent. 2. Male or female patients ≥ 18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Subjects with locally advanced or metastatic solid tumors failed to prior SOCs and no appropriate SOC to treat the current disease per investigator's judgement. 5. Life expectancy ≥ 3 months. 6. Subjects with adequate organ function. 7. Men or women of childbearing potential (which refer to men or women who have not been surgically sterilized and pre-menopausal women) must use a highly effective method of contraception during the study and continue to take contraception measures for 6 months after the last dose of the study drug. Exclusion Criteria: 1. Pregnant or lactating women. 2. Prior systemic anticancer treatment within 5 half-lives or 4 weeks before the first dose (whichever is shorter). 3. Active viral infection requiring systemic therapy during the screening period. 4. Hypertension that cannot be well-controlled with medical treatment. 5. Cardiovascular disease of clinical significance. 6. Subjects with any active infection that requires anti-infective therapy judged by the investigators. 7. Subjects are not suitable for participating the study judged by the investigators. 8. Subjects with poor compliance, who are unwilling to or unable to follow study procedures.
References
Publications (0)
Data not yet available
No reference posted for this study.