Umbrella Study of Sasanlimab Combined With Targeted Therapies in Participants With Non Small Cell Lung Cancer

A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined With Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants With Non-Small Cell Lung Cancer (NSCLC)

Sponsors

Commanditaire principal: Pfizer

La source Pfizer
Bref résumé

Phase 1b/Phase 2 open-label, multi-center, parallel group umbrella study.

Sasanlimab (a PD-1 antagonist monoclonal antibody) will be combined with a different targeted therapy in each sub-study. The Phase1b part of each sub-study will evaluate the safety of the combination and select the dose for the Phase 2 part. The Phase 2 part of each sub-study will evaluate the anti-tumor activity of the combination.

Situation globale Not yet recruiting
Date de début October 22, 2020
Date d'achèvement November 27, 2024
Date d'achèvement principale November 27, 2024
Phase Phase 1/Phase 2
Type d'étude Interventional
Résultat primaire
Mesure Plage de temps
Percentage of participants with Dose-limiting toxicities (DLT) First dose (Cycle 1 Day 1) to end of first treatment cycle (about 21-28 days)
Durable Objective Response Rate - Percentage of Participants With Objective Response First dose (Cycle 1 Day 1) to End of Study Treatment (up to about 24 months); each cycle is about 28 days
Résultat secondaire
Mesure Plage de temps
Number of participants with Treatment-Emergent Adverse Events First dose (Cycle 1 Day 1) to 30 days after last dose (up to about 24 months); each cycle is about 28 days
Percentage of participants with Treatment-Emergent Adverse Events First dose (Cycle 1 Day 1) to 30 days after last dose (up to about 24 months); each cycle is about 28 days
Number of Participants with Treatment-Emergent Laboratory Abnormalities First dose (Cycle 1 Day 1) to 30 days after last dose (up to about 24 months); each cycle is about 28 days
Percentage of Participants with Treatment-Emergent Laboratory Abnormalities First dose (Cycle 1 Day 1) to 30 days after last dose (up to about 24 months); each cycle is about 28 days
Durable Objective Response Rate - Percentage of Participants With Objective Response First dose (Cycle 1 Day 1) to End of Study Treatment (up to about 24 months); each cycle is about 28 days
Objective Response Rate-Percentage of Participants with Objective Response First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months); each cycle is about 28 days
Duration of Response (DR) First objective response to progressive disease or death (up to about 24 months); each cycle is about 28 days
Time to Tumor Response (TTR) First dose (Cycle 1 Day 1) up to first objective response. Each cycle is about 28 days
Progression-Free Survival (PFS) First dose (Cycle 1 Day 1) to progressive disease or death (up to about 24 months). Each cycle is about 28 days
Overall Survival First dose (Cycle 1 Day 1) to death (up to about 40 months); each cycle is about 28 days
Incidence of Anti-Drug Antibody (ADA) for sasanlimab First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months); each cycle is about 28 days
Neutalizing antibody (NAb) titers for sasanlimab First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months); each cycle is about 28 days
Correlation between Objective Response and PD-L1 expression at baseline First dose (Cycle 1 Day 1) to End of Study Treatment (up to about 24 months); each cycle is about 28 days
PK Parameter AUC (Area Under the Curve) First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months). Day 1, 8, and 15 of Cycle 1. Day 1 of Cycle 2 and 3. Days 1 and 8 of Cycle 5. Day 1 of Cycles 7, 10, 13, and then every 6 cycles until EOT. Each cycle is about 28 days
PK Parameter Ctrough First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months). Day 1, 8, and 15 of Cycle 1. Day 1 of Cycle 2 and 3. Days 1 and 8 of Cycle 5. Day 1 of Cycles 7, 10, 13, and then every 6 cycles until EOT. Each cycle is about 28 days
PK Parameter Cmax (Maximum Observed Plasma Concentration) First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months). Day 1, 8, and 15 of Cycle 1. Day 1 of Cycle 2 and 3. Days 1 and 8 of Cycle 5. Day 1 of Cycles 7, 10, 13, and then every 6 cycles until EOT. Each cycle is about 28 days
PK Parameter Tmax (Time to Reach Maximum Observed Plasma Concentration) First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months). Day 1, 8, and 15 of Cycle 1. Day 1 of Cycle 2 and 3. Days 1 and 8 of Cycle 5. Day 1 of Cycles 7, 10, 13, and then every 6 cycles until EOT. Each cycle is about 28 days
Inscription 375
État
Intervention

Type d'intervention: Drug

Nom de l'intervention: Sasanlimab Prefillled syringe

La description: prefilled syringe

Étiquette du groupe d'armements: Sub-Study A

Type d'intervention: Drug

Nom de l'intervention: Encorafenib

La description: capsules

Étiquette du groupe d'armements: Sub-Study A

Type d'intervention: Drug

Nom de l'intervention: Binimetinib

La description: tablets

Étiquette du groupe d'armements: Sub-Study A

Admissibilité

Critères:

Inclusion Criteria Umbrella Phase 1b & 2:

- Histologically or cytologically confirmed locally advanced/metastatic (Stage IIIB-IV) NSCLC.

- At least one measurable lesion per RECIST v1.1 at Screening.

- ECOG Performance Status 0 or 1.

- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.

- Adequate hepatic, renal, and bone marrow function.

Additional Inclusion Criteria for Sub-Study A Phase 1b &2:

-BRAFV600E mutation in tumor tissue or plasma as determined by a local laboratory PCR or NGS assay and documented in a local pathology report.

Additional Inclusion Criteria for Sub-Study A Phase 1b only:

-Any line of therapy for locally advanced/metastatic NSCLC.

Additional Inclusion Criteria for Sub-Study A Phase 2 only:

-Previously untreated for locally advanced/metastatic NSCLC

Exclusion Criteria Umbrella Phase 1b &2:

- Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.

- Active, non-infectious pneumonitis, pulmonary fibrosis, or known history of immune-mediated pneumonitis.

- Active infection requiring systemic therapy.

- Clinically significant cardiovascular disease.

- Other malignancy within 2 years of first dose, with exceptions.

- Symptomatic brain metastasis, with exceptions.

Additional Exclusion Criteria for Sub-Study A Phase 1b &2:

- EGFR mutation, ALK fusion oncogene, or ROS1 rearrangement.

- Prior treatment with any BRAF inhibitor or MEK inhibitor.

Additional Exclusion Criteria for Sub-Study A Phase 2 only:

-Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.

Le sexe: All

Âge minimum: 18 Years

Âge maximum: N/A

Volontaires en santé: No

Officiel général
Nom de famille Rôle Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Contact général

Nom de famille: Pfizer CT.gov Call Center

Téléphone: 1-800-718-1021

Email: [email protected]

Emplacement
Établissement: California Cancer Associates for Research and Excellence, Inc (cCARE)
Pays d'implantation

United States

Date de vérification

October 2020

Partie responsable

Type: Sponsor

Mots clés
A un accès étendu No
Parcourir l'état
Nombre d'armes 1
Groupe d'armes

Étiquette: Sub-Study A

Type: Experimental

La description: Sasanlimab will be administered subcutaneously. Encorafenib & binimetinib will be administered orally. Treatments will be administered until progressive disease, unacceptable AE, participant withdraws, or study is terminated.

Données patient Yes
Informations sur la conception de l'étude

Allocation: Non-Randomized

Modèle d'intervention: Parallel Assignment

Objectif principal: Treatment

Masquage: None (Open Label)

La source: ClinicalTrials.gov