FPA150 in Patients With Advanced Solid Tumors (FPA150-001)
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|ClinicalTrials.gov Identifier: NCT03514121|
Recruitment Status : Active, not recruiting
First Posted : May 2, 2018
Last Update Posted : February 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Ovarian Cancer Endometrial Cancer Advanced Solid Tumors||Biological: FPA150 Biological: Pembrolizumab||Early Phase 1|
This is a Phase 1a/1b open-label, multicenter study to evaluate the dosing, safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of FPA150 as monotherapy and in combination with pembrolizumab, an anti-PD1 antibody, in patients with advanced solid tumors.
This study includes a Phase 1a FPA150 Monotherapy Dose Escalation, Phase 1a Monotherapy Dose Exploration, Phase 1a combination Safety Lead-in (FPA150 + pembrolizumab), a Phase 1b FPA150 Monotherapy Dose Expansion, and a Phase 1b combination Dose Expansion (FPA150 + pembrolizumab).
The Phase 1a Monotherapy Dose Escalation will include an initial accelerated titration design followed by a standard 3+3 dose escalation design until the MTD and/or RD for Phase 1b is determined. The Phase 1a combination Safety Lead-In will start enrolling once the FPA150 monotherapy RD is identified in Phase 1a monotherapy dose escalation and will continue until the FPA150 MTD/RD in combination is identified. Phase 1a FPA150 monotherapy Dose Exploration may include cohorts that may enroll beyond 3 patients whose tumors express high levels of B7-H4 protein and/or have varying levels of B7H4 expression including low (<10% IHC 2+ or 3+ scores) or no expression on their tumor cells (up to 20 additional patients across all dose levels) to further evaluate safety, PK, pharmacodynamics, and clinical activity at that dose (to be conditional upon the dose level clearing DLT criteria).
Phase 1b will be the Dose Expansion (monotherapy and combination) portion of the study.
Enrollment into Phase 1b Dose Expansion will begin after identification of the MTD and/or RD in Phase 1a (monotherapy and Safety Lead-in). Preliminary efficacy will be evaluated in Phase 1b in planned expansion cohorts that include patients with specific tumor types that are B7-H4+ advanced solid tumors.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||278 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm trial with multiple cohorts|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1a/1b Study of FPA150, an Anti-B7-H4 Antibody, in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||March 27, 2018|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2024|
Experimental: Phase 1a dose escalation/1b dose expansion
The study consists of Phase 1a dose escalation, Phase 1a dose exploration, Phase 1a combination safety-lead-in and Phase 1b dose expansion
A monoclonal antibody against B7-H4
An anti-PD1 antibody
- For Phase 1a dose escalation, to determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of FPA150 [ Time Frame: Through study completion, an average of 24 weeks ]Tolerability
- For Phase 1a dose escalation, dose exploration and combination safety lead-in the number of participants with adverse events as assessed by the latest version of CTCAE [ Time Frame: Through study completion, an average of 24 weeks ]Safety
- For Phase 1b, number of participants with adverse events as assessed by the latest version of CTCAE at the maximum tolerated dose (MTD) and/or recommended dose (RD) of FPA150 [ Time Frame: Through study completion, average 24 weeks ]Safety
- Area under serum concentration-time curve of FPA150 in day*µg/mL [ Time Frame: Through study completion, an average of 24 weeks ]Pharmacokinetic profile FPA150
- Maximum serum concentration of FPA150 in µg/mL [ Time Frame: Through study completion, an average of 24 weeks ]Pharmacokinetic Profile FPA150
- Trough serum concentration of FPA150 in µg/mL [ Time Frame: Through study completion, an average of 24 weeks ]Pharmacokinetic Profile FPA150
- Clearance of FPA150 in mL/day/kg [ Time Frame: Through study completion, an average of 24 weeks ]Pharmacokinetic Profile FPA150
- Terminal Half-Life of FPA150 in day [ Time Frame: Through study completion, an average of 24 weeks ]Pharmacokinetic Profile FPA150
- Volume of distribution (mL/kg) of FPA150 [ Time Frame: Through study completion, an average of 24 weeks ]Pharmacokinetic Profile FPA150
- Incidence of treatment emergent anti-FPA150 antibody response (levels in serum) [ Time Frame: Through study completion, an average of 24 weeks ]Immunogenicity FPA150
- For Phase 1b, to evaluate the overall response rate (ORR) defined as the total number of patients with complete response (CR) or partial response (PR) per RECIST v1.1 divided by the total number of patients who are evaluable for a response [ Time Frame: Through study completion, an average of 24 weeks ]Efficacy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514121