QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors

Brief summary public domain (ClinicalTrials.gov)

This is a multi-center, 2-part phase 1b/2 study of AMG 655 in combination with AMG 479 to be conducted in the United States and Spain. Part 1 is a dose escalation segment to identify a dose of AMG 655 in combination with AMG 479 that is safe and tolerable. Part 2 will evaluate the safety and estimate the efficacy of AMG 655 at the dose selected in Part 1 in combination with AMG 479 for the treatment of patients with advanced NSCLC (non-squamous histology; squamous histology), CRC, pancreatic cancer, ovarian cancer, and sarcoma.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Dose-limiting Toxicities [Time from first dose up to 24 months]. Count Of Participants, Participants. Part 1 Cohort 1 (n=3): 0; Part 1 Cohort 2 (n=3): 0; Part 1 Cohort 3 (n=3): 0.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Objective Response Rate [Time from first dose up to 24 months]. Count Of Participants, Participants. Part 1 Cohort 1 (n=3): 1; Part 1 Cohort 2 (n=3): 0; Part 1 Cohort 3 (n=3): 0; Part 2 Cohort 1 (n=15): 0; Part 2 Cohort 2 (n=7): 0; Part 2 Cohort 3 (n=16): 0; Part 2 Cohort 4 (n=16): 0; Part 2 Cohort 5 (n=9): 0; Part 2 Cohort 6 (n=15): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression Free Survival [Time from first dose up to 24 months]. Median, months (95% Confidence Interval). Part 1 Cohort 1 (n=3): 1.4 (1.1 to 15.4); Part 1 Cohort 2 (n=3): 4.9 (1.6 to 5.5); Part 1 Cohort 3 (n=3): 1.3 (1.1 to 2.4); Part 2 Cohort 1 (n=15): 1.6 (1.3 to 3.7); Part 2 Cohort 2 (n=8): 3.3 (1.9 to 5.4); Part 2 Cohort 3 (n=16): 1.5 (1.3 to 2.6); Part 2 Cohort 4 (n=16): 1.4 (1.2 to 2.3); Part 2 Cohort 5 (n=9): 2.8 (1.6 to 3.9); Part 2 Cohort 6 (n=16): 1.3 (1.2 to 1.7).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation [Time from first dose up to 24 months]. Count Of Participants, Participants. AMG 655 - Binding antibody positive at any time: Part 1 Cohort 1 (n=1): 0; Part 1 Cohort 2 (n=2): 0; Part 1 Cohort 3 (n=1): 0; Part 2 Cohort 1 (n=11): 0; Part 2 Cohort 2 (n=5): 0; Part 2 Cohort 3 (n=13): 0; Part 2 Cohort 4 (n=7): 1; Part 2 Cohort 5 (n=7): 0; Part 2 Cohort 6 (n=10): 0. AMG 655 - Neutralizing antibody positive at any time: Part 1 Cohort 1 (n=1): 0; Part 1 Cohort 2 (n=2): 0; Part 1 Cohort 3 (n=1): 0; Part 2 Cohort 1 (n=11): 0; Part 2 Cohort 2 (n=5): 0; Part 2 Cohort 3 (n=13): 0; Part 2 Cohort 4 (n=7): 0; Part 2 Cohort 5 (n=7): 0; Part 2 Cohort 6 (n=10): 0. AMG 479 - Binding antibody positive at any time: Part 1 Cohort 1 (n=1): 0; Part 1 Cohort 2 (n=2): 0; Part 1 Cohort 3 (n=1): 0; Part 2 Cohort 1 (n=11): 2; Part 2 Cohort 2 (n=5): 0; Part 2 Cohort 3 (n=13): 0; Part 2 Cohort 4 (n=7): 0; Part 2 Cohort 5 (n=7): 0; Part 2 Cohort 6 (n=10): 0. AMG 479 - Neutralizing antibody positive at any time: Part 1 Cohort 1 (n=1): 0; Part 1 Cohort 2 (n=2): 0; Part 1 Cohort 3 (n=1): 0; Part 2 Cohort 1 (n=11): 0; Part 2 Cohort 2 (n=5): 0; Part 2 Cohort 3 (n=13): 0; Part 2 Cohort 4 (n=7): 0; Part 2 Cohort 5 (n=7): 0; Part 2 Cohort 6 (n=10): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

To Evaluate the Concentration Level of AMG 655 [Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)]. Median, μg/mL (Full Range). Cycle 1-End of Infusion: Part 1 Cohort 1 (n=3): 17.5 (17.3 to 19.4); Part 1 Cohort 2 (n=2): 59.0 (59.0 to 59.0); Part 1 Cohort 3 (n=2): 313 (261 to 365); Part 2 Cohort 1 (n=13): 244 (240 to 247); Part 2 Cohort 2 (n=7): 266 (266 to 266); Part 2 Cohort 3 (n=14): 240 (115 to 319); Part 2 Cohort 4 (n=14): 224 (130 to 293); Part 2 Cohort 5 (n=7): 327 (275 to 341); Part 2 Cohort 6 (n=13): 247 (91.3 to 392). Cycle 3-End of infusion: Part 1 Cohort 1 (n=3): 23.6 (23.6 to 23.6); Part 1 Cohort 2 (n=2): 62.3 (62.3 to 62.3); Part 1 Cohort 3 (n=2): 302 (302 to 302); Part 2 Cohort 1 (n=13): 448 (448 to 448); Part 2 Cohort 3 (n=14): 311 (233 to 380); Part 2 Cohort 4 (n=14): 253 (253 to 253); Part 2 Cohort 5 (n=7): 423 (356 to 490); Part 2 Cohort 6 (n=13): 371 (328 to 466).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

To Evaluate the Concentration Level of AMG 479 [Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)]. Median, μg/mL (Full Range). Cycle 1-End of infusion: Part 1 Cohort 1 (n=3): 272 (198 to 279); Part 1 Cohort 2 (n=2): 268 (268 to 268); Part 1 Cohort 3 (n=2): 303 (257 to 349); Part 2 Cohort 1 (n=13): 215 (193 to 237); Part 2 Cohort 2 (n=7): 297 (297 to 297); Part 2 Cohort 3 (n=14): 227 (130 to 634); Part 2 Cohort 4 (n=14): 236 (121 to 391); Part 2 Cohort 5 (n=9): 324 (248 to 439); Part 2 Cohort 6 (n=13): 254 (169 to 445). Cycle 3-End of Infusion: Part 1 Cohort 1 (n=3): 308 (308 to 308); Part 1 Cohort 3 (n=2): 338 (338 to 338); Part 2 Cohort 1 (n=13): 404 (404 to 404); Part 2 Cohort 3 (n=14): 262 (205 to 364); Part 2 Cohort 4 (n=14): 249 (249 to 249); Part 2 Cohort 5 (n=9): 323 (300 to 381); Part 2 Cohort 6 (n=13): 365 (244 to 420).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Time to Response [Time from first dose up to 24 months].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration of Response [Time from objective response to 24 months].