Description:
To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the
maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Title
- Brief Title: Study of AMG 650 in Adult Participants With Advanced Solid Tumors
- Official Title: A Phase 1, Multicenter, Open-label, Dose-Exploration and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 650 in Subjects With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
20190131
- NCT ID:
NCT04293094
Conditions
Interventions
Drug | Synonyms | Arms |
---|
AMG 650 | | Dose Expansion Phase Group 1: TNBC |
Purpose
To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the
maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Exploration Phase | Experimental | Participants will receive AMG 650 in 1 of 3 alternative schedules. The maximum tolerated dose (MTD) of each schedule will be estimated using isotonic regression (Ji et al, 2010). The Recommended Phase 2 Dose (RP2D) may be identified based on emerging safety, efficacy, and pharmacodynamics (PD) data prior to reaching an MTD. | |
Dose Expansion Phase Group 1: TNBC | Experimental | Participants with locally advanced or metastatic triple negative breast cancer (TNBC), will be administered with the preliminary RP2D identified from the dose exploration part of the study. | |
Dose Expansion Phase Group 2: HGSOC | Experimental | Participants with locally advanced or metastatic high grade serous ovarian cancer (HGSOC), will be administered with the preliminary RP2D identified from the dose exploration part of the study. | |
Eligibility Criteria
Inclusion Criteria:
- Male and female ≥ 18 years old
- Triple Negative Breast Cancer participants only: Participant must have histologically
or cytologically confirmed metastatic or locally recurrent estrogen receptor
(ER)-negative (<1% by immunohistochemistry [IHC]), progesterone receptor (PR)-negative
(<1% IHC) and human epidermal growth factor receptor 2 (Her2)-negative (either
fluorescent in situ hybridisation [FISH] negative, 0 or 1+ by IHC, or IHC2+ and FISH
negative per ASCO/CAP definition) breast cancer. Participant must be
relapsed/refractory to at least one line of systemic chemotherapy in the metastatic
setting or intolerant of existing therapy(ies) known to provide clinical benefit for
their condition. Prior exposure to an immune checkpoint inhibitor is allowed.
- Platinum-Resistant High Grade Serous Ovarian Cancer, primary peritoneal cancer and/or
fallopian-tube cancer participants only: Participant must have histologically or
cytologically confirmed diagnosis of metastatic or unresectable high grade serous
ovarian cancer, with platinum-resistance defined as progression during or within 6
months of a platinum-containing regimen. Prior exposure to platinum-resistant
recurrence therapy is allowed.
- Serous Endometrial Cancer participants only (Dose Exploration only): Participant must
have histologically or cytologically confirmed diagnosis of metastatic or recurrent
serous endometrial cancer, and be relapsed/refractory to at least one line of systemic
therapy in the metastatic/recurrent setting or intolerant of existing therapy(ies)
known to provide clinical benefit for their condition.
- Participants with advanced or metastatic solid tumor with TP53MUT (Dose Exploration
only, as assessed by local testing) that is unresectable and relapsed/refractory to at
least one line of systemic chemotherapy or intolerant.
Exclusion Criteria:
- Active brain metastases.
- Primary CNS tumor, hematological malignancies or lymphoma.
- Uncontrolled pleural effusions(s), pericardial effusion, or ascites.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Participants with Dose Limiting Toxicities (DLTs) |
Time Frame: | Up to 12 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Progression-free Survival (PFS) |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Clinical Benefit Rate (CBR) |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Time to Response (TTR) |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Time to Progression (TTP) |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Maximum Plasma Concentration (Cmax) of AMG 650 |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Time to Maximum Plasma Concentration (Tmax) of AMG 650 |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval for AMG 650 |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Amgen |
Trial Keywords
- AMG 650
- Locally-advanced/metastatic solid tumors
- p53 mutation
- Serous like endometrial cancers
- Triple negative breast cancer (TNBC)
- High grade serous ovarian cancer (HGSOC)
Last Updated
July 16, 2021