Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Solid Tumor Malignancies

Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Solid Tumor Malignancies

Experimental: Cohort A-1 -BT8009 Monotherapy Dose Escalation
Participants will receive increasing doses of BT8009. It is expected that approximately 60 participants will participate in this dose escalation arm.

Drug: BT8009
Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.

Experimental: Cohort A-2 -BT8009 in Combination with Pembrolizumab Dose De-Escalation
Participants will receive BT8009 and a standard dose of pembrolizumab. It is expected that up to 15 participants will participate in this dose de-escalation arm.

Drug: BT8009
Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.
Drug: Pembrolizumab
Participants in Cohorts A-2 and B-7 will receive 200 mg IV over 30-minute infusion of pembrolizumab on Day 1 of each 21-day cycle.
Other Name: Keytruda

Experimental: Cohort B-1 – BT8009 Monotherapy Dose Expansion
Participants with urothelial cancer and previously exposed to enfortumab vedotin (EV) will receive a selected dose of BT8009. Up to 43 participants could be enrolled in this dose expansion cohort.

Drug: BT8009
Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.

Experimental: Cohort B-2- BT8009 Monotherapy Dose Expansion
Participants with urothelial cancer and not previously exposed to enfortumab vedotin (EV) will receive a selected dose of BT8009 on day 1 and day 8 of a 3-weekly cycle. Up to 43 participants could be enrolled in this dose expansion cohort.

Drug: BT8009
Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.

Experimental: Cohort B-3- BT8009 Monotherapy Dose Expansion
Participants with urothelial cancer and not previously exposed to enfortumab vedotin (EV) will receive a weekly selected dose of BT8009. Up to 43 participants could be enrolled in this dose expansion cohort.

Drug: BT8009
Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.

Experimental: Cohort B-4- BT8009 Monotherapy Dose Expansion
Participants with ovarian cancer will receive a selected dose of BT8009. Up to 29 participants could be enrolled in this dose expansion cohort.

Drug: BT8009
Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.

Experimental: Cohort B-5- BT8009 Monotherapy Dose Expansion
Participants with triple-negative breast cancer (TNBC) will receive a selected dose of BT8009. Up to 29 participants could be enrolled in this dose expansion cohort.

Drug: BT8009
Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.

Experimental: Cohort B-6- BT8009 Monotherapy Dose Expansion
Participants with non-small cell lung cancer (NSCLC) will receive a selected dose of BT8009. Up to 29 participants could be enrolled in this dose expansion cohort.

Drug: BT8009
Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.

Experimental: Cohort B-7- BT8009 in Combination with Pembrolizumab Dose Expansion
Participants with first-line, cisplatin-ineligible, metastatic urothelial cancer will receive a selected dose of BT8009 and standard dose of pembrolizumab. Approximately 20 participants could be enrolled in this dose expansion cohort.

Drug: BT8009
Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.
Drug: Pembrolizumab
Participants in Cohorts A-2 and B-7 will receive 200 mg IV over 30-minute infusion of pembrolizumab on Day 1 of each 21-day cycle.
Other Name: Keytruda

Experimental: Cohort C – Renal Insufficiency BT8009 Monotherapy Dose Expansion
Participants with renal insufficiency will receive a selected dose of BT8009. Approximately 18 participants could be enrolled in this dose expansion cohort.

Drug: BT8009
Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.

Source: View full study details on ClinicalTrials.gov

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November 29, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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