Clinical trialPhase 1Completed
Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors
A Phase 1, Multicenter, Open-label, Dose Exploration and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 994 Monotherapy and Combination of AMG 994 and AMG 404 in Subjects With Advanced Solid Tumors
- Outcome
- Outcome unknown
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- 29 April 2021
- Expected end
- 5 June 2023
- Enrollment
- 11 participants
- Sites
- 17
- Primary outcomes
- Number of Participants Who Experienced Dose Limiting Toxicities (DLTs); Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
- Sponsor
- Industry
- Results posted
- 2025-01-06
- Last update
- 6 January 2025
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Brief summary public domain (ClinicalTrials.gov)
The primary objective of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD)/maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) of AMG 994 as monotherapy and AMG 994 in combination with AMG 404 in participants with advanced solid tumors.
Detailed description public domain (ClinicalTrials.gov)
AMG 994 will be administered by short term intravenous (IV) infusion once weekly in each 28-day cycle and AMG 404 will be administered by short-term IV infusion once every 4 weeks (Q4W) in a 28 day cycle (on day 1 of cycle 2 and beyond). The study will be conducted in 2 parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) [Up to Day 28 of Cycle 1 (one cycle = 28 days)]. Number, Number of participants. Cohort 1 (Low Dose) (n=3): 0; Cohort 2 (High Dose (n=8): 3.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) [From first dose of investigational product through 140 days after last dose (AMG 994 or AMG 404, whichever is later), or end of study (whichever is first); median (min, max) duration was 12.5 ( 1.48, 19.32) months.]. Number, Number of participants. All TEAEs: Cohort 1 (Low Dose) (n=3): 3; Cohort 2 (High Dose) (n=8): 8. All Grade ≥ 3 TEAEs: Cohort 1 (Low Dose) (n=3): 3; Cohort 2 (High Dose) (n=8): 6. All SAEs: Cohort 1 (Low Dose) (n=3): 3; Cohort 2 (High Dose) (n=8): 6. All Fatal AEs (FAEs): Cohort 1 (Low Dose) (n=3): 2; Cohort 2 (High Dose) (n=8): 6. All AMG 994 related TEAEs: Cohort 1 (Low Dose) (n=3): 2; Cohort 2 (High Dose) (n=8): 4. AMG 994 related Grade ≥ 3 TEAEs: Cohort 1 (Low Dose) (n=3): 0; Cohort 2 (High Dose) (n=8): 1. AMG 994 related SAEs: Cohort 1 (Low Dose) (n=3): 0; Cohort 2 (High Dose) (n=8): 0. AMG 994 related FAEs: Cohort 1 (Low Dose) (n=3): 0; Cohort 2 (High Dose) (n=8): 0. All AMG 404 related TEAEs: Cohort 1 (Low Dose) (n=3): 1; Cohort 2 (High Dose) (n=8): 4. AMG 404 related TEAEs Grade ≥ 3 TEAEs: Cohort 1 (Low Dose) (n=3): 0; Cohort 2 (High Dose) (n=8): 1. AMG 404 related SAEs: Cohort 1 (Low Dose) (n=3): 0; Cohort 2 (High Dose) (n=8): 0. AMG 404 related FAEs: Cohort 1 (Low Dose) (n=3): 0; Cohort 2 (High Dose) (n=8): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Objective Response (OR) Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Up to approximately 19.32 months]. Number, Number of participants. CR: Cohort 1 (Low Dose) (n=3): 0; Cohort 2 (High Dose) (n=8): 0. PR: Cohort 1 (Low Dose) (n=3): 0; Cohort 2 (High Dose) (n=8): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Duration of Response (DoR) Per Modified RECIST 1.1 [Up to approximately 19.32 months]. Median, Months (95% Confidence Interval). Cohort 2 (High Dose) (n=2): 11.09 (11.05 to NA) [Upper limit not reached.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) Per Modified RECIST 1.1 [Up to approximately 19.32 months]. Median, Months (95% Confidence Interval). Cohort 1 (Low Dose) (n=3): 5.99 (5.03 to NA) [Upper CI limit not reached due to the low number of observations.]; Cohort 2 (High Dose) (n=8): 12.50 (1.48 to NA) [Upper CI limit not reached due to the low number of observations.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival Per Modified RECIST 1.1 [Up to approximately 19.32 months]. Median, Months (95% Confidence Interval). Cohort 1 (Low Dose) (n=3): 2.63 (2.63 to NA) [Upper CI limit not reached due to the low number of observations.]; Cohort 2 (High Dose) (n=8): 1.61 (0.92 to 13.65).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Progression (TTP) Per Modified RECIST 1.1 [Up to approximately 19.32 months]. Median, Months (95% Confidence Interval). Cohort 1 (Low Dose) (n=3): 2.63 (2.63 to NA) [Upper CI limit not reached due to the low number of observations.]; Cohort 2 (High Dose) (n=8): 1.74 (0.92 to 13.65).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Subsequent Therapy [Up to approximately 19.32 months]. Median, Months (95% Confidence Interval). Cohort 1 (Low Dose) (n=3): NA (4.74 to NA) [Median and upper CI limit not reached due to the low number of observations.]; Cohort 2 (High Dose) (n=8): NA (16.64 to NA) [Median and upper CI limit not reached due to the low number of observations.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Maximum Serum Concentration (Cmax) of AMG 994 [Cycle 1 and 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose); Cycle 1, Day 22 (pre-dose, EOI, 6, and 12 hours post dose)]. Mean, ng/mL (Standard Deviation). Cycle 1, Day 1: Cohort 1 (Low Dose) (n=3): 667 (1150); Cohort 2 (High Dose) (n=8): 2450 (1140). Cycle 1, Day 22: Cohort 1 (Low Dose) (n=3): 4450 (3020); Cohort 2 (High Dose) (n=8): 2550 (1290). Cycle 2, Day 1: Cohort 1 (Low Dose) (n=3): 2340 (3180); Cohort 2 (High Dose) (n=8): 2830 (1260).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Maximum Serum Concentration (Tmax) of AMG 994 [Cycle 1 and 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose); Cycle 1, Day 22 (pre-dose, EOI, 6, and 12 hours post dose)]. Mean, hours (Standard Deviation). Cycle 1, Day 1: Cohort 1 (Low Dose) (n=3): 8.4 (15); Cohort 2 (High Dose) (n=8): 1.4 (0.68). Cycle 1, Day 22: Cohort 1 (Low Dose) (n=3): 3.7 (1.1); Cohort 2 (High Dose) (n=8): 1.5 (0.74). Cycle 2, Day 1: Cohort 1 (Low Dose) (n=3): 3.0 (0.0096); Cohort 2 (High Dose) (n=8): 2.7 (2.0).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Minimum Observed Serum Concentration (Cmin) of AMG 994 [Cycle 1 and 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose); Cycle 1, Day 22 (pre-dose, EOI, 6, and 12 hours post dose)]. Mean, ng/mL (Standard Deviation). Cycle 1, Day 1: Cohort 1 (Low Dose) (n=3): 0.00 (0.00); Cohort 2 (High Dose) (n=7): 0.00 (0.00). Cycle 1, Day 22: Cohort 1 (Low Dose) (n=3): 0.00 (0.00); Cohort 2 (High Dose) (n=7): 0.00 (0.00). Cycle 2, Day 1: Cohort 1 (Low Dose) (n=3): 0.00 (0.00); Cohort 2 (High Dose) (n=7): 0.00 (0.00).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 994 [Cycle 1 and 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose); Cycle 1, Day 22 (pre-dose, EOI, 6, and 12 hours post dose)]. Mean, h*ng/mL (Standard Deviation). Cycle 1, Day 1: Cohort 1 (Low Dose) (n=3): 12100 (NA) [SD not calculable when n=1]; Cohort 2 (High Dose) (n=8): 15000 (16700). Cycle 1, Day 22: Cohort 1 (Low Dose) (n=3): 18900 (15000); Cohort 2 (High Dose) (n=8): 21900 (23100). Cycle 2, Day 1: Cohort 1 (Low Dose) (n=3): 6460 (8010); Cohort 2 (High Dose) (n=8): 22900 (23300).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Area Under the Serum Concentration-time Curve During a Dosing Interval (AUCtau) of AMG 994 [Cycle 1 and 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose); Cycle 1, Day 22 (pre-dose, EOI, 6, and 12 hours post dose)]. Mean, h*ng/mL (Standard Deviation). Cycle 1, Day 1: Cohort 1 (Low Dose) (n=3): 20300 (35200); Cohort 2 (High Dose) (n=7): 20400 (21400). Cycle 1, Day 22: Cohort 1 (Low Dose) (n=3): 24500 (18400); Cohort 2 (High Dose) (n=7): 45400 (61100). Cycle 2, Day 1: Cohort 1 (Low Dose) (n=3): 8260 (10100); Cohort 2 (High Dose) (n=7): 29500 (31100).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Terminal Half-life (t1/2) of AMG 994 [Cycle 1 and 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose); Cycle 1, Day 22 (pre-dose, EOI, 6, and 12 hours post dose)]. Mean, hours (Standard Deviation). Cycle 1, Day 1: Cohort 2 (High Dose) (n=3): 4.97 (2.90). Cycle 1, Day 22: Cohort 1 (Low Dose) (n=1): 5.24 (NA) [SD not calculable when n=1]. Cycle 2, Day 1: Cohort 2 (High Dose) (n=3): 4.76 (3.55).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Cmax of AMG 404 [Cycle 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose)]. Mean, ng/mL (Standard Deviation). Cohort 1 (Low Dose) (n=3): 158 (22.1); Cohort 2 (High Dose) (n=5): 145 (47.9).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Tmax of AMG 404 [Cycle 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose)]. Mean, hours (Standard Deviation). Cohort 1 (Low Dose) (n=3): 0.080 (0.049); Cohort 2 (High Dose) (n=5): 0.11 (0.074).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Cmin of AMG 404 [Cycle 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose)]. Mean, ng/mL (Standard Deviation). Cohort 1 (Low Dose) (n=3): 20.8 (11.1); Cohort 2 (High Dose) (n=3): 22.8 (18.2).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
AUClast of AMG 404 [Cycle 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose)]. Mean, h*ng/mL (Standard Deviation). Cohort 1 (Low Dose) (n=3): 1280 (322); Cohort 2 (High Dose) (n=5): 1160 (618).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
AUCtau of AMG 404 [Cycle 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose)]. Mean, h*ng/mL (Standard Deviation). Cohort 1 (Low Dose) (n=3): 1280 (322); Cohort 2 (High Dose) (n=5): 1290 (576).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
T1/2 of AMG 404 [Cycle 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose)]. Mean, hours (Standard Deviation). Cohort 1 (Low Dose) (n=1): 13.0 (NA) [SD not calculable when n=1]; Cohort 2 (High Dose) (n=1): 9.55 (NA) [SD not calculable when n=1].