BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiocity Biopharmaceutics Co., Ltd.
About this trial
This is a Phase 1/2, open-label, dose escalation and expansion study to assess the safety, pharmacokinetics, and preliminary efficacy of BC3195 in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors.
Eligibility criteria
Qualifiers
Provide written informed consent.
Aged at least 18 years at the time of ICF signature.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to the first dose of study treatment.
Life expectancy of ≥ 3 months based on the Investigator's assessment.
Disqualifiers
Has received prior systemic anticancer treatment, including investigational agents, within 5 half-lives or 4 weeks prior to the first dose of study treatment (whichever is shorter). Has received Traditional Chinese Medication within 7 days prior to study treatment.
Participants who have received major surgery (defined as requiring general anesthesia and >24-hour inparticipant hospitalization) within 4 weeks prior to the first dose of study treatment. Participant must have recovered adequately from complications from the intervention prior to starting study treatment.
Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis.
Has had an allogeneic tissue/solid organ transplant.
Trial design
Treatments tested in this trial
- BC3195
- Pembrolizumab/KEYTRUDA®
Treatment groups
111 Participants
are divided into 1 treatment groupSponsors and collaborators
Biocity Biopharmaceutics Co., Ltd.
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov