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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
BC3195
DrugBC3195 for injection is a sterile lyophilized powder in a 20 mg single-dose vial. Administration: Administered via intravenous (IV) infusion, with dosing and frequency determined according to Phase I (dose escalation) and Phase Ⅱ(dose expansion) study design
Pembrolizumab/KEYTRUDA®
DrugPembrolizumab will be administered at 200 mg as a 30 minute IV infusion Q3W prior to BC3195. Sites should make every effort to target infusion timing to be as close to 30 minutes as possible.
Treatment groups
111 Participants
are divided into 1 treatment groupGroup A: BC3195 in Combination with PembrolizumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of partcipants with Dose Limiting Toxicities (DLTs)
The incidence of dose-limiting toxicity (DLT) at different doses of BC3195 combined with pembrolizumab in patients with locally advanced or metastatic solid tumors. DLT will be assessed at the end of Cycle 1.
Time frame
Throughout the dose escalation phase, an average of 1 year2
Investigator-assessed Objective Response Rate (ORR) of BC3195 combined with pembrolizumab in participants with solid tumors
ORR (per investigator's assessment based on RECIST v1.1) defined as the proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR).
Time frame
Throughout the dose expansion phase, an average of 2.5 yearsSecondary outcomes
1
Investigator-assessed progression-free survival (PFS) of BC3195 combined with pembrolizumab in participants with solid tumors
PFS (per investigator's assessment based on RECIST v1.1) defined as the time interval from first dose to the first documented PD or death due to any cause, whichever occurs first.
Time frame
Through study completion, an average of 2.5 years2
Investigator-assessed disease control rate (DCR) of BC3195 combined with pembrolizumab in participants with solid tumors
DCR (per investigator's assessment based on RECIST v1.1) defined as the proportion of participants with a BOR of CR, PR, or stable disease (SD).
Time frame
Through study completion, an average of 2.5 years3
Investigator-assessed duration of response (DOR) of BC3195 combined with pembrolizumab in participants with solid tumors
DOR (per investigator's assessment based on RECIST v1.1) defined as the time interval from the first documentation of response (CR or PR) to the first documentation of PD or death, whichever occurred first.
Time frame
Through study completion, an average of 2.5 years4
Overall survival (OS) of BC3195 combined with pembrolizumab in participants with solid tumors
OS defined as the time interval from the first dose to death due to any cause.
Time frame
Through study completion, an average of 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Biocity Biopharmaceutics Co., Ltd.
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov