NCT04733027: Clever Peptide

First-in-human Phase I to Evaluate PEP-010 as Single Agent and in Combination With Paclitaxel or With Gemcitabine (CleverPeptide)

Active, enrolled EARLY_PHASE1 Last updated 22 January 2026

What this trial tests

EARLY_PHASE1 trial testing Dose escalation, first-in-human phase I clinical trial with an Expansion phase in Metastatic Solid Tumor Cancer in 57 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

18 May 2021

Primary endpoint
30 December 2026

31 January 2027

Quick facts

Lead sponsor	Institut Curie
Phase	EARLY_PHASE1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	57
Start date	18 May 2021
Primary completion	30 December 2026
Estimated completion	31 January 2027
Sites	4 locations across France

Drugs / interventions tested

• Dose escalation, first-in-human phase I clinical trial with an Expansion phase

Conditions studied

• Metastatic Solid Tumor Cancer — all drugs for Metastatic Solid Tumor Cancer →

Sponsor

Institut Curie — full company profile →

Who can join

18 and older, any sex, with Metastatic Solid Tumor Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, non-controlled, multicenter, dose escalation, first-in-human phase I clinical trial with an expansion phase designed to assess the safety, tolerability, PK and PD parameters, and preliminary antitumor activity of intravenous dosing of PEP-010 as single agent and in combination with paclitaxel or with gemcitabine

PEP-010 will be administered, in a Part 1, as single agent in patients with solid cancers who are not amenable to standard treatment, or in combination in patients who are eligible for the paclitaxel therapy, and in a Part 2 only in combination in:

Cohort 1 (expansion cohort, phase 1b): metastatic pancreatic ductal carcinoma (PDAC) who received at least one previous systemic chemotherapy and eligible for paclitaxel therapy.

Cohort 2 (dose escalation cohort, phase 1a): metastatic pancreatic ductal carcinoma or advanced/metastatic ovarian cancer (OC) eligible for gemcitabine-based therapy

Publications & conference data

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

1. Advance in peptide-based drug development: delivery platforms, therapeutics and vaccines.
   Xiao W, Jiang W, Chen Z, Huang Y, et al · · 2025 · cited 144× · PMID 40038239 · DOI 10.1038/s41392-024-02107-5
2. The role of cell-penetrating peptides in potential anti-cancer therapy.
   Zhou M, Zou X, Cheng K, Zhong S, et al · · 2022 · cited 89× · PMID 35593206 · DOI 10.1002/ctm2.822
3. Cell-Penetrating Peptides: Applications in Tumor Diagnosis and Therapeutics.
   Stiltner J, McCandless K, Zahid M. · · 2021 · cited 32× · PMID 34204007 · DOI 10.3390/pharmaceutics13060890
4. Cell-Penetrating Peptide-Based Delivery of Macromolecular Drugs: Development, Strategies, and Progress.
   Sun Z, Huang J, Fishelson Z, Wang C, et al · · 2023 · cited 31× · PMID 37509610 · DOI 10.3390/biomedicines11071971
5. Exploring the Chemical Features and Biomedical Relevance of Cell-Penetrating Peptides.
   Moreno-Vargas LM, Prada-Gracia D. · · 2024 · cited 14× · PMID 39795918 · DOI 10.3390/ijms26010059
6. Cancer-Targeting Applications of Cell-Penetrating Peptides.
   Moreno-Vargas LM, Prada-Gracia D. · · 2024 · cited 11× · PMID 39795861 · DOI 10.3390/ijms26010002
7. Binding and Kinetic Analysis of Human Protein Phosphatase PP2A Interactions with Caspase 9 Protein and the Interfering Peptide C9h.
   Dorgham K, Murail S, Tuffery P, Savier E, et al · · 2022 · cited 7× · PMID 36297489 · DOI 10.3390/pharmaceutics14102055
8. The first-in-class pro-apoptotic peptide PEP-010 is effective in monotherapy and in combination with paclitaxel on resistant ovarian adenocarcinoma cell models.
   Lacroix A, Farhat R, Robert A, Brenner C, et al · · 2024 · cited 4× · PMID 39170706 · DOI 10.3389/fphar.2024.1444973