Description:
This is an open-label, multicenter, dose escalation and expansion study designed to evaluate
the safety, tolerability, and preliminary anti-tumor activity of BND-22. The study will
enroll advanced cancer patients with unresectable or metastatic disease who are refractory to
or are not candidates for standard approved therapy and will be comprised of two parts - an
initial "3 + 3" dose escalation phase followed by a dose expansion phase.
Title
- Brief Title: Study of BND-22 in Participants With Advanced Solid Tumors
- Official Title: A Phase 1/2, Dose Escalation and Expansion Study of the Safety, Tolerability, and Anti-tumor Activity of BND-22 in Patients With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
BND-22-001
- NCT ID:
NCT04717375
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| BND-22 | | BND-22 Dose Escalation |
Purpose
This is an open-label, multicenter, dose escalation and expansion study designed to evaluate
the safety, tolerability, and preliminary anti-tumor activity of BND-22. The study will
enroll advanced cancer patients with unresectable or metastatic disease who are refractory to
or are not candidates for standard approved therapy and will be comprised of two parts - an
initial "3 + 3" dose escalation phase followed by a dose expansion phase.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| BND-22 Dose Escalation | Experimental | Standard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. BND-22 will be administered intravenously (IV), every 2 weeks (Q2W). | |
| BND-22 Dose Expansion | Experimental | Will include three expansion cohorts enrolling patients with advanced stage squamous cell carcinoma of the head and neck, gastric or gastroesophageal junction adenocarcinoma, and non-small cell lung cancer. Enrollment will start after the recommended phase 2 dose (RP2D) of BND-22 has been established. BND-22 will be administered intravenously (IV), every 2 weeks (Q2W). | |
Eligibility Criteria
Inclusion Criteria:
- Patients with unresectable or metastatic disease who are refractory to or are not
candidates for standard approved therapy
- Histologic confirmation of malignancy
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1
- Participants must have adequate organ function as defined by lab tests
- Part 1: Following tumor types: Breast cancer, cervical cancer, colorectal cancer,
adenocarcinoma or squamous cell carcinoma of the esophagus, gastric or
gastroesophageal junction adenocarcinoma, squamous cell carcinoma of the head and
neck, hepatobiliary cancers (hepatocellular carcinoma (HCC), gallbladder cancer,
cholangiocarcinoma), non-small cell lung cancer, renal cell carcinoma, squamous cell
carcinoma of the skin, or urothelial carcinoma
- Part 2: Following tumor types: Squamous cell carcinoma of the head and neck, Gastric
or gastroesophageal junction adenocarcinoma, Non-small cell lung cancer
Exclusion Criteria:
- Active, known or suspected autoimmune disease
- Condition requiring systemic treatment with either corticosteroids or other
immunosuppressive medications
- Brain or leptomeningeal metastases
- Known history of positive test for HIV
- Non-HCC patients: acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV);
HCC patients: untreated active HBV or dual infection with HBV/HCV
- Participants after solid organ or allogeneic hematopoietic stem cell transplant
- History of life-threatening toxicity related to prior immune therapy
- Unstable or deteriorating cardiovascular disease within the previous 6 months
- Any major surgery within 4 weeks of study drug administration
- Prior/Concomitant Therapy:
- Cytotoxic/Non-cytotoxic anti-cancer agents, unless at least 4 weeks have elapsed from
last dose
- Use of other investigational drugs within 28 days
- Prior treatment with macrophage or natural killer (NK) cells activating therapies
- Administration of a live attenuated vaccine within 28 days
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Part 1: Incidence of treatment-emergent adverse events (TEAEs) dose limiting toxicities (DLT) |
| Time Frame: | Cycle 1 (28 days) |
| Safety Issue: | |
| Description: | Incidence of TEAEs meeting protocol defined DLT criteria |
Secondary Outcome Measures
| Measure: | Part 1: Maximum observed plasma concentration [Cmax] |
| Time Frame: | Through study completion, an average of 2 months |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Maximum observed plasma concentration [Cmax] |
| Time Frame: | Through study completion, an average of 3 months |
| Safety Issue: | |
| Description: | |
| Measure: | Part 1: Terminal elimination half-life [T1/2] |
| Time Frame: | Through study completion, an average of 2 months |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Terminal elimination half-life [T1/2] |
| Time Frame: | Through study completion, an average of 3 months |
| Safety Issue: | |
| Description: | |
| Measure: | Part 1: Area under the plasma concentration-time curve [AUC] |
| Time Frame: | Through study completion, an average of 2 months |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Area under the plasma concentration-time curve [AUC] |
| Time Frame: | Through study completion, an average of 3 months |
| Safety Issue: | |
| Description: | |
| Measure: | Part 1: Incidence of anti-drug antibodies (ADA) |
| Time Frame: | Through study completion, an average of 5 months |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Incidence of anti-drug antibodies (ADA) |
| Time Frame: | Through study completion, an average of 6 months |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Progression Free Survival |
| Time Frame: | Through study completion, an average of 3 months |
| Safety Issue: | |
| Description: | Time from the date of first dose of study drug to the date of first documented disease progression or death |
| Measure: | Part 2: Duration of Response |
| Time Frame: | Through study completion, an average of 6 months |
| Safety Issue: | |
| Description: | Duration between first documentation of CR or PR to first documentation of disease progression or death |
| Measure: | Part 2: Incidence of Serious Adverse Events and Adverse Events |
| Time Frame: | Through study completion, an average of 6 months |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Biond Biologics |
Last Updated
July 13, 2021
