Spots Global Cancer Trial Database for First-in-human Phase I to Evaluate PEP-010 as Single Agent and in Combination With Paclitaxel or With Gemcitabine (CleverPeptide)

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Trial Identification

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

Official Title: Dose Escalation, First-in-human Clinical Trial to Evaluate the Safety, Pharmacokinetics and Preliminary Antitumor Activity of PEP-010, Administered as Single Agent and in Combination With Paclitaxel or With Gemcitabine in Patients With Metastatic Solid Cancer

Study ID: NCT04733027

Conditions

Metastatic Solid Tumor Cancer

Interventions

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

Study Description

Brief Summary: 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

Detailed Description: Part 1 : PEP-010 was administered on days 1, 2 and 3 every week. Treatment was administered until disease progression, unacceptable toxicity, death or withdrawal of consent, whichever occured first. Each cycle was of 21 days duration. The initial starting dose of PEP-010, DL1 was selected based on pre-clinical data at 0.15 mg/kg. The other doses per injection from DL2 to DL7 are 0.3, 0.6; 1.2; 2.5; 5; 10 and 15 mg/kg. For patients in Arm B, PEP-010 was combined with Paclitaxel, at a dose of 80 mg/m², weekly until disease progression or unacceptable toxicity. Paclitaxel will be administered according to local guidelines. Main objective for Dose escalation cohorts was to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of PEP-010 when administered as single agent (MTD1/RP2D1), and in combination with paclitaxel (MTD2/RP2D2) by recording the dose-limiting toxicities (DLTs). Secondary objectives were * To evaluate the safety and tolerability of PEP-010 when administered as single agent, and in combination with paclitaxel. * To assess the pharmacokinetics (PK) of PEP-010 as single agent, and in combination with paclitaxel in Dose escalation cohorts. * To assess the pharmacodynamic (PD) effects of PEP-010 as single agent, and in combination with paclitaxel. * To evaluate the preliminary antitumor activity of PEP-010 alone and in combination with paclitaxel, using Objective Response Rate (ORR), Progression-Free Survival (PFS) according to RECIST1.1, duration of response, and Overall Survival (OS). * To assess the immunogenicity of PEP-010 as single agent, and in combination with paclitaxel in Dose escalation cohorts. Part 2 : In Part 2 - Cohort 1, PDAC patients will receive PEP-010 at dose 2.5 mg/kg in combination with paclitaxel administered at a dose of 80 mg/m² weekly. In Part 2 - Cohort 2, PDAC and OC patients will receive PEP-010 at doses 1.2 to 10 mg/kg (short dose escamation) in combination with gemcitabine administered at a dose of 1000 mg/m² weekly during 3 weeks followed by a week without infusion. Main objectives for Part 2 (Cohort 1) • To determine the efficacy of PEP-010 in combination with paclitaxel in patients with pancreatic ductal adenocarcinoma by assessment of the objective response rate. Part 2 (Cohort 2) * To determine the MTD of PEP-010 when administered in combination with gemcitabine. * To determine the RP2D of PEP-010 when administered in combination with gemcitabine. Secondary objectives for Part 2 (Cohorts 1 and 2 ) * To evaluate the safety and tolerability of PEP-010 when administered in combination with paclitaxel or with gemcitabine. * To complete the pharmacokinetics (PK) of PEP-010 in combination with paclitaxel. * To assess the pharmacokinetics (PK) of PEP-010 in combination with gemcitabine. * To assess the pharmacokinetics (PK) of paclitaxel, when administered in combination with PEP-010. * To assess the pharmacokinetics (PK) of gemcitabine, when administered in combination with PEP-010. * To characterize the PD effects of PEP-010 in combination with paclitaxel or with gemcitabine. * To evaluate the preliminary antitumor activity of PEP-010 in combination with paclitaxel at the RP2D in term of PFS, duration of response and OS (Cohort 1). * To evaluate the preliminary antitumor activity of PEP-010 in combination with gemcitabine using the ORR, PFS, duration of response and OS (Cohort 2). * To assess the immunogenicity of PEP-010 in combination with paclitaxel or gemcitabine