Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies.

Conditions

Nectin-4 Expressing Advanced Malignancies.

Brief summary

1. Incidence of TEAEs, including lab, ECG, vital sign abnormalities (CTCAE v5.0) (A-1,A-2, B-8, B-9, &C)., 2. Incidence of dose-limiting tox (A-1,A-2)., 3. ORR per RECIST v1.1 criteria (B)., 4. Plasma concentrations of zelenectide pevedotin (BT8009) and MMAE with derivations including Cmax, Cmin, AUC, and elimination t(1/2) (D).

Detailed description

1. ORR, DOR, clinical benefit rate (CR + PR + SD ≥ 16 weeks), PFS, all assessed per RECIST v1.1 criteria, and OS (A, C and D)., 2. Plasma concentrations of zelenectide pevedotin (BT8009) and MMAE with derivations including Cmax, Cmin, AUC, and elimination half-life t(1/2) (A, B, C and D)., 3. Measurement of ADA (A, C and D)., 4. TEAEs and laboratory, ECG and vital sign abnormalities using CTCAE v5.0 criteria (B, D)., 5. DOR, clinical benefit rate (CR + PR + SD ≥ 16 weeks), PFS, all assessed per RECIST v1.1 criteria, and OS (B)., 6. ORR by Nectin-4 status per RECIST v1.1 criteria (B)., 7. Plasma concentrations of zelenectide pevedotin (BT8009) and MMAE with derivations including Cmax, Cmin, AUC, and elimination half-life t(1/2) (B)., 8. Measurement of ADA (B).

Related papers

No related papers found yet.

Interventions

DRUGBT8009

DRUGZelenectide Pevedotin

DRUGPEMBROLIZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Incidence of TEAEs, including lab, ECG, vital sign abnormalities (CTCAE v5.0) (A-1,A-2, B-8, B-9, &C)., 2. Incidence of dose-limiting tox (A-1,A-2)., 3. ORR per RECIST v1.1 criteria (B)., 4. Plasma concentrations of zelenectide pevedotin (BT8009) and MMAE with derivations including Cmax, Cmin, AUC, and elimination t(1/2) (D).	—

Secondary

Measure	Time frame
1. ORR, DOR, clinical benefit rate (CR + PR + SD ≥ 16 weeks), PFS, all assessed per RECIST v1.1 criteria, and OS (A, C and D)., 2. Plasma concentrations of zelenectide pevedotin (BT8009) and MMAE with derivations including Cmax, Cmin, AUC, and elimination half-life t(1/2) (A, B, C and D)., 3. Measurement of ADA (A, C and D)., 4. TEAEs and laboratory, ECG and vital sign abnormalities using CTCAE v5.0 criteria (B, D)., 5. DOR, clinical benefit rate (CR + PR + SD ≥ 16 weeks), PFS, all assessed per RECIST v1.1 criteria, and OS (B)., 6. ORR by Nectin-4 status per RECIST v1.1 criteria (B)., 7. Plasma concentrations of zelenectide pevedotin (BT8009) and MMAE with derivations including Cmax, Cmin, AUC, and elimination half-life t(1/2) (B)., 8. Measurement of ADA (B).	—

Measure

Time frame

1. ORR, DOR, clinical benefit rate (CR + PR + SD ≥ 16 weeks), PFS, all assessed per RECIST v1.1 criteria, and OS (A, C and D)., 2. Plasma concentrations of zelenectide pevedotin (BT8009) and MMAE with derivations including Cmax, Cmin, AUC, and elimination half-life t(1/2) (A, B, C and D)., 3. Measurement of ADA (A, C and D)., 4. TEAEs and laboratory, ECG and vital sign abnormalities using CTCAE v5.0 criteria (B, D)., 5. DOR, clinical benefit rate (CR + PR + SD ≥ 16 weeks), PFS, all assessed per RECIST v1.1 criteria, and OS (B)., 6. ORR by Nectin-4 status per RECIST v1.1 criteria (B)., 7. Plasma concentrations of zelenectide pevedotin (BT8009) and MMAE with derivations including Cmax, Cmin, AUC, and elimination half-life t(1/2) (B)., 8. Measurement of ADA (B).

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Countries

France, Italy, Spain

Outcome results

None listed