NCT03861403

A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors

Terminated Phase 1 Last updated 30 November 2023

What this trial tests

Phase 1 trial testing TRX518 in Solid Tumors in 10 participants. Terminated before completion.

Timeline

20 May 2019

Primary endpoint
14 July 2020

14 July 2020

Quick facts

Lead sponsor	Leap Therapeutics, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	20 May 2019
Primary completion	14 July 2020
Estimated completion	14 July 2020
Sites	4 locations across United States

Drugs / interventions tested

• TRX518 — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Avelumab (avelumab) — full drug profile →

Conditions studied

• Solid Tumors — all drugs for Solid Tumors →
• Advanced Triple Negative Breast Cancer — all drugs for Advanced Triple Negative Breast Cancer →
• Advanced Hormone Receptor Positive/Endocrine Refractory Breast Cancer — all drugs for Advanced Hormone Receptor Positive/Endocrine Refractory Breast Cancer →
• Advanced Metastatic Castration-Resistant Prostate Cancer — all drugs for Advanced Metastatic Castration-Resistant Prostate Cancer →

Sponsor

Leap Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Solid Tumors or Advanced Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1b/2a dose escalation and expansion, multi-center study to be conducted in 2 phases:

* Phase 1b

* Dose Escalation Part 1 (Doublet Therapy)
* Dose Escalation Part 2 (Triplet Therapy)
* Phase 2a

* Dose Expansion (Triplet Therapy)

Approximately 125 adult patients with histologically confirmed advanced solid tumors requiring therapy will be enrolled in the study. It is expected that approximately 24 patients will be enrolled in up to 4 cohorts, 2 cohorts in Dose Escalation Part 1 and 2 cohorts in Dose Escalation Part 2, of up to 6 patients per cohort. Up to 98 additional patients will be enrolled in the Dose Expansion phase of the study to achieve 88 evaluable patients (i.e., received at least 1 dose of study drug(s) and have 1 evaluable post-baseline modified RECIST v1.1 tumor response assessment; for mCRPC, assessment of soft tissue response will be per modified RECIST v1.1 and bone progression assessment will be per PCWG3 guidelines or discontinued treatment due to death, toxicity, or clinical progression) over 4 independent expansion groups.In either phase (1b or 2a), patients discontinuing for reasons unrelated to study treatment toxicity prior to completion of Cycle (C) 1 may be replaced to achieve the number of required evaluable patients per cancer type following consultation with the Sponsor. Data from each cohort in the Dose Escalation phase will be evaluated independently for safety and dose limiting toxicities (DLTs) prior to dose escalation and again prior to the Dose Expansion phase.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent advances in systemic therapy for hepatocellular carcinoma.
   Zhang H, Zhang W, Jiang L, Chen Y. · · 2022 · cited 150× · PMID 35000616 · DOI 10.1186/s40364-021-00350-4
2. Targeting PD-1/PD-L1 in cancer immunotherapy: An effective strategy for treatment of triple-negative breast cancer (TNBC) patients.
   Kumar S, Chatterjee M, Ghosh P, Ganguly KK, et al · · 2023 · cited 72× · PMID 37397537 · DOI 10.1016/j.gendis.2022.07.024
3. New emerging targets in cancer immunotherapy: the role of GITR.
   Buzzatti G, Dellepiane C, Del Mastro L. · · 2020 · cited 53× · PMID 32817129 · DOI 10.1136/esmoopen-2020-000738
4. Beyond PD-1/PD-L1 Inhibition: What the Future Holds for Breast Cancer Immunotherapy.
   Chrétien S, Zerdes I, Bergh J, Matikas A, et al · · 2019 · cited 47× · PMID 31060337 · DOI 10.3390/cancers11050628
5. Targeting tumor-infiltrating tregs for improved antitumor responses.
   Qin D, Zhang Y, Shu P, Lei Y, et al · · 2024 · cited 36× · PMID 38500876 · DOI 10.3389/fimmu.2024.1325946
6. Immune-Checkpoint Inhibitors in Platinum-Resistant Ovarian Cancer.
   Indini A, Nigro O, Lengyel CG, Ghidini M, et al · · 2021 · cited 28× · PMID 33916221 · DOI 10.3390/cancers13071663
7. Modern Immunotherapy in the Treatment of Triple-Negative Breast Cancer.
   Wesolowski J, Tankiewicz-Kwedlo A, Pawlak D. · · 2022 · cited 20× · PMID 36010854 · DOI 10.3390/cancers14163860
8. Tackling Immune Targets for Breast Cancer: Beyond PD-1/PD-L1 Axis.
   Tabana Y, Okoye IS, Siraki A, Elahi S, et al · · 2021 · cited 16× · PMID 33747948 · DOI 10.3389/fonc.2021.628138