Metastatic Solid Tumor CancerEarly Phase 1Clever PeptideNCT04733027
First-in-human Phase I to Evaluate PEP-010 as Single Agent and in Combination With Paclitaxel or With Gemcitabine (CleverPeptide)
A Early Phase 1 study testing Dose escalation, first-in-human phase I clinical trial with an Expansion phase in people with Metastatic Solid Tumor Cancer, run by Institut Curie at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumor Cancer
- What is being tested?
- Dose escalation, first-in-human phase I clinical trial with an Expansion phase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 4 sitesFrance
- Study dates
- 18 May 2021to 11 Jun 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part 1 Arms A and B:
- Arm A: Patients must have histologically confirmed diagnosis of recurrent and/or metastatic solid tumors, who are not amenable to standard therapy, with exceptions as defined in the non-inclusion criteria,
- Arm B: Patients must have histologically confirmed diagnosis of recurrent and/or metastatic solid tumors. Patients must be eligible for a treatment with paclitaxel as single agent. Patients who are eligible for standard of care paclitaxel-based combination therapy should not be included in the trial unless they have been previously exposed to that specific combination therapy. Specifically :
- Patients with ovarian cancer must have received prior therapy with paclitaxel as part of standard of care in combination with carboplatin.
- Patients with triple negative breast cancer are eligible for the trial since paclitaxel as single agent is standard of care in this disease.
- Age ≥ 18 years,
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- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1,
- Patients must have measurable disease (as per RECIST version 1.1),
- Patient ability to comply with the collection of tumor biopsies, and tumors must be accessible for biopsy,
- Adequate bone marrow function as defined by: Absolute Neutrophil Count (ANC) of ≥ 1.5 x 109/L, platelet count of ≥ 100 x 109/L, and hemoglobin of ≥ 9 g/dL),
- Adequate liver function, as determined by a serum total bilirubin ≤ 1.5 Upper Limit of Normal (ULN), AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastases),
- Adequate renal function, as determined by a serum creatinine ≤ 1.5 x ULN,
- Provision of signed written informed consent,
- Patient ability to comply with protocol requirements,
- If the patient is female:
- Patient must be postmenopausal, surgically sterile, or they must agree to use a physical barrier method of contraception in addition to either an intrauterine device or hormonal contraception until at least 6 months after termination of study drug or must refrain from heterosexual activity during this same period.
- Patients of childbearing potential must have a negative pregnancy test within the seven days prior to the first study drug administration.
- If the patient is male:
- Patient must abstain from heterosexual activity or must agree to use an acceptable method of contraception (e.g., condom) during the study for at least 6 months after termination of study drug.
- Patients covered by a health insurance system;
- Part 2 Cohort 1 Pancreatic Ductal adenocarcinoma (PDAC)
- Age ≥ 18 years,
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1,
- Patients must have measurable disease (as per RECIST version 1.1),
- Patient ability to comply with the collection of tumor biopsies, and tumors must be accessible for biopsy,
- Adequate bone marrow function as defined by: Absolute Neutrophil Count (ANC) of ≥ 1.5 x 109/L, platelet count of ≥ 100 x 109/L, and hemoglobin of ≥ 9 g/dL),
- Adequate liver function, as determined by a serum total bilirubin ≤ 1.5 Upper Limit of Normal (ULN), AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastases),
- Adequate renal function, as determined by a serum creatinine ≤ 1.5 x ULN,
- Provision of signed written informed consent,
- Patient ability to comply with protocol requirements,
- If the patient is female:
- Patient must be postmenopausal, surgically sterile, or they must agree to use a physical barrier method of contraception in addition to either an intrauterine device or hormonal contraception until at least 6 months after termination of study drug or must refrain from heterosexual activity during this same period.
- Patients of childbearing potential must have a negative pregnancy test within the seven days prior to the first study drug administration.
- If the patient is male:
- Patient must abstain from heterosexual activity or must agree to use an acceptable method of contraception (e.g., condom) during the study for at least 6 months after termination of study drug.
- Patients covered by a health insurance system
- Histologically confirmed metastatic pancreatic ductal adenocarcinoma (mixed histology is acceptable as long adenocarcinoma is the dominant histological subtype)
- Patient should have received at least one previous line of systemic treatment in metastatic setting
- No previous disease progression under taxane therapy or 12-month free interval since last taxane therapy.
- Part 2 Cohort 2 Pancreatic Ductal adenocarcinoma (PDAC) or Ovarian Cancer (OC)
- Age ≥ 18 years,
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1,
- Patients must have measurable disease (as per RECIST version 1.1),
- Patient ability to comply with the collection of tumor biopsies, and tumors must be accessible for biopsy,
- Adequate bone marrow function as defined by: Absolute Neutrophil Count (ANC) of ≥ 1.5 x 109/L, platelet count of ≥ 100 x 109/L, and hemoglobin of ≥ 9 g/dL),
- Adequate liver function, as determined by a serum total bilirubin ≤ 1.5 Upper Limit of Normal (ULN), AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastases),
- Adequate renal function, as determined by a serum creatinine ≤ 1.5 x ULN,
- Provision of signed written informed consent,
- Patient ability to comply with protocol requirements,
- If the patient is female:
- Patient must be postmenopausal, surgically sterile, or they must agree to use a physical barrier method of contraception in addition to either an intrauterine device or hormonal contraception until at least 6 months after termination of study drug or must refrain from heterosexual activity during this same period.
- Patients of childbearing potential must have a negative pregnancy test within the seven days prior to the first study drug administration.
- If the patient is male:
- Patient must abstain from heterosexual activity or must agree to use an acceptable method of contraception (e.g., condom) during the study for at least 6 months after termination of study drug.
- Patients covered by a health insurance system
- Patient must be eligible but not previously treatment with gemcitabine.
- Specific Pancreatic Ductal adenocarcinoma (PDAC)
- Histologically confirmed metastatic pancreatic ductal adenocarcinoma (mixed histology is acceptable as long adenocarcinoma is the dominant histological subtype)
- Specific ovarian cancer (OC)
- Patient has been diagnosed with recurrent epithelial ovarian, peritoneal, or fallopian tube carcinoma.
- Subjects had disease recurrence or progression during prior chemotherapy with platinum-based regimens or within 6 months after the last dose of chemotherapy with platinum-based regimens (for at least 4 cycles of treatment)
- Patient should have received at least one previous line of treatment in platinum-resistant setting.
- Non-inclusion criteria: Part 1 Arms A and B, Part 2 Cohorts 1 and 2
- Arm B and Cohort 1: Allergy or hypersensitivity to paclitaxel or components of the paclitaxel formulation,
- Cohort 2: Allergy or hypersensitivity to gemcitabine or components of the gemcitabine formulation,
- Allergy or hypersensitivity to PEP-010 formulation (Trehalose, Tween 20),
- Patients with known or suspected Central Nervous System (CNS) metastases including leptomeningeal metastasis (except patients with radiographically stable, asymptomatic previously irradiated lesion provided patient is ≥ 3 weeks beyond completing cranial irradiation),
- Evidence of significant, uncontrolled concomitant diseases, which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina), or pulmonary disease (including obstructive pulmonary disease and history of symptomatic bronchospasm),
- Concomitant cancer in the past 3 years except prostate cancer controlled by hormone therapy, cutaneous cancers (except melanoma) and in situ carcinoma,
- Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), immunotherapy within 21 days of first receipt of study drug,
- Prior investigational agent within 28 days of first PEP-010 administration,
- Hormone therapy within 14 days of first receipt of study drug, with exception of Gonadotropin-Releasing Hormone (GnRH) or Luteinizing-Hormone-Releasing Hormone (LHRH) agonists used for advanced prostate cancer, if indicated,
- Prior relevant toxicities from chemotherapy or radiotherapy which have not regressed to grade ≤1 severity except alopecia (NCI-CTCAE version 5.0),
- Patients with acute infection.
- Any other uncontrolled diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding or any other medical condition that, in the opinion of the investigator, contraindicates the use of an investigational drug, or will impose excessive risk to the patient,
- Patients with known HIV, HBV and HCV infections,
- Patients with known active Sars Cov 2 infection
- Pregnant or lactating women,
- Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent,
- Person deprived of liberty or under guardianship.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
France4 sites
CLCC F.Baclesse Caen
Caen
Institut Curie
Paris, 75005
Institut de Cancerologie de l'Ouest- ICO
Saint-Herblain, 44805
Gustave Roussy
Villejuif
About this study
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
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:
Read more
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
Read the 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
- Conditions
- Metastatic Solid Tumor Cancer
- Being tested
- Dose escalation, first-in-human phase I clinical trial with an Expansion phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose escalation, first-in-human phase I clinical trial with an Expansion phaseCombination product
PEP-010 will be administered on days 1, 2 and 3 every week, as a 3-hour intravenous infusion. Treatment will be administered until disease progression, unacceptable toxicity, death or withdrawal of consent, whichever occurs first. Each cycle will be of 21 days duration.
| Study group | Role | What they receive |
|---|---|---|
| Part 2 cohort 1 : PEP010 in combination with paclitaxel | Experimental | Fort part 2 the Cohort 1 will include patients with PDAC treated with the combination of PEP-010 at the dose of 2.5 mg/kg and weekly paclitaxel 80 mg/m². Receives: Combination Product: Dose escalation, first-in-human phase I clinical trial with an Expansion phase |
| Part 2 cohort 2 : PEP010 in combination with gemcitabine | Experimental | In arm B, the dose escalation phase will begin with DL4 (1.2 mg/kg) and will follow a 3+3 design For part 2 Cohort 2 will include patients with PDAC or OC treated with the combination of PEP-010 in ascending doses, and gemcitabine at 1000 mg/m2.
Four doses of PEP-010 will be tested: 1.2 mg/kg, 2.5 mg/kg, 5 mg/kg and 10 mg/kg, according to a 3+3 dose escalation design.
Once a MTD is achieved, and in light of safety, PK, and PD data, two dosing schedules will be further explored based on TSC recommendations. Each dosing schedule will be evaluated in a separate cohort to generate more data and inform on the choice of the RP2D, as per the recommendations of the FDA (Project Optimus). Patients will be randomized simultaneously in the two dose cohorts, each would include approximately 6 - 10 patients. Receives: Combination Product: Dose escalation, first-in-human phase I clinical trial with an Expansion phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
For Part 1 (Dose escalation) and Part 2 (Cohort 2), the primary endpoints are the rate of occurrence of DLT within cycle 1 (21 days) after initiation of the study treatment for both parts.
The DLT is defined as any clinically significant non-hematological toxicity ≥ grade 3 and any hematological toxicity ≥ grade 4 of treatment-related adverse event
Measured: 21 days after study treatment initiation
Part 2 Cohort 1: The primary endpoint is the ORR (objective response rate), based on local investigator assessment, per RECIST 1.1.
the ORR (objective response rate), defined as the proportion of patients who have achieved a complete response (CR) or partial response (PR) within the first 6 months
Measured: 6 months after study treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start18 May 2021
- Primary completion11 Jun 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Solid Tumor CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1 dose escalation Part 2 expansion cohort and short dose escalation cohort Randomization in the escalation dose cohort once MTD defined
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Paule SABLIN, MD, PhD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733027
- Sponsor's protocol ID
- IC 2018-06
- Acronym
- Clever Peptide
- Status last verified
- Jul 2026
- First submitted
- 22 Jan 2021
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets documents generated under the project will be disseminated in accordance with Institut Curie policies.
Publications
1.Ezzalfani M. et al. The role of the expansion cohort in phase I trials in oncology: guidelines of the phase I HUB. Bull Cancer. 2015 Jan;102(1):73-82. doi:10.1016/j.bulcan. 2014.10.001. Epub 2015 Jan 2. Review. French. 2.M3(R2) guideline : Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 3.ICH S9 - Nonclinical Evaluation for Anticancer Pharmaceuticals EMEA/CHMP/ICH/646107/2008 4.Masini et al. Histamin-releasing properties of polysorbate 80 in vitro and in vivo: correlation 1254 with its hypotensive action in the dog. Agents Actions 1985 Sep; 16(6):470-7. 5.Guideline on repeated dose toxicity - CPMP/SWP/1042/99 Rev 1 6.Storer B.E. Design and Analysis of Phase I Clinical Trials. Biometrics, Vol. 45, No. 3 (Sep., 1989), pp. 925-937. 7.Seshan V.E. et al. Clinical Trial Design and Data Analysis Functions, Package clinfun, version 1.0.15 (Apr 2018)
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04733027
- Acronym / sponsor ID
- Clever Peptide / IC 2018-06
- Conditions
- Metastatic Solid Tumor Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part 1 dose escalation Part 2 expansion cohort and short dose escalation cohort Randomization in the escalation dose cohort once MTD defined
| Arm | Type | Receives |
|---|---|---|
| Part 2 cohort 1 : PEP010 in combination with paclitaxel | Experimental | Combination Product: Dose escalation, first-in-human phase I clinical trial with an Expansion phaseFort part 2 the Cohort 1 will include patients with PDAC treated with the combination of PEP-010 at the dose of 2.5 mg/kg and weekly paclitaxel 80 mg/m². |
| Part 2 cohort 2 : PEP010 in combination with gemcitabine | Experimental | Combination Product: Dose escalation, first-in-human phase I clinical trial with an Expansion phaseIn arm B, the dose escalation phase will begin with DL4 (1.2 mg/kg) and will follow a 3+3 design For part 2 Cohort 2 will include patients with PDAC or OC treated with the combination of PEP-010 in ascending doses, and gemcitabine at 1000 mg/m2. Four doses of PEP-010 will be tested: 1.2 mg/kg, 2.5 mg/kg, 5 mg/kg and 10 mg/kg, according to a 3+3 dose escalation design. Once a MTD is achieved, and in light of safety, PK, and PD data, two dosing schedules will be further explored based on TSC recommendations. Each dosing schedule will be evaluated in a separate cohort to generate more data and inform on the choice of the RP2D, as per the recommendations of the FDA (Project Optimus). Patients will be randomized simultaneously in the two dose cohorts, each would include approximately 6 - 10 patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (80 listed)
- Arm A: Patients must have histologically confirmed diagnosis of recurrent and/or metastatic solid tumors, who are not amenable to standard therapy, with exceptions as defined in the non-inclusion criteria,
- Arm B: Patients must have histologically confirmed diagnosis of recurrent and/or metastatic solid tumors. Patients must be eligible for a treatment with paclitaxel as single agent. Patients who are eligible for standard of care paclitaxel-based combination therapy should not be included in the trial unless they have been previously exposed to that specific combination therapy. Specifically :
- Age ≥ 18 years,
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1,
- Patients must have measurable disease (as per RECIST version 1.1),
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose escalation, first-in-human phase I clinical trial with an Expansion phasePEP-010 will be administered on days 1, 2 and 3 every week, as a 3-hour intravenous infusion. Treatment will be administered until disease progression, unacceptable toxicity, death or withdrawal of consent, whichever occurs first. Each cycle will be of 21 days duration. | Combination product | Part 2 cohort 1 : PEP010 in combination with paclitaxel, Part 2 cohort 2 : PEP010 in combination with gemcitabine |
Primary outcome
For Part 1 (Dose escalation) and Part 2 (Cohort 2), the primary endpoints are the rate of occurrence of DLT within cycle 1 (21 days) after initiation of the study treatment for both parts.
Time frame: 21 days after study treatment initiation
The DLT is defined as any clinically significant non-hematological toxicity ≥ grade 3 and any hematological toxicity ≥ grade 4 of treatment-related adverse event
Part 2 Cohort 1: The primary endpoint is the ORR (objective response rate), based on local investigator assessment, per RECIST 1.1.
Time frame: 6 months after study treatment initiation
the ORR (objective response rate), defined as the proportion of patients who have achieved a complete response (CR) or partial response (PR) within the first 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background1.Ezzalfani M. et al. The role of the expansion cohort in phase I trials in oncology: guidelines of the phase I HUB. Bull Cancer. 2015 Jan;102(1):73-82. doi:10.1016/j.bulcan. 2014.10.001. Epub 2015 Jan 2. Review. French. 2.M3(R2) guideline : Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 3.ICH S9 - Nonclinical Evaluation for Anticancer Pharmaceuticals EMEA/CHMP/ICH/646107/2008 4.Masini et al. Histamin-releasing properties of polysorbate 80 in vitro and in vivo: correlation 1254 with its hypotensive action in the dog. Agents Actions 1985 Sep; 16(6):470-7. 5.Guideline on repeated dose toxicity - CPMP/SWP/1042/99 Rev 1 6.Storer B.E. Design and Analysis of Phase I Clinical Trials. Biometrics, Vol. 45, No. 3 (Sep., 1989), pp. 925-937. 7.Seshan V.E. et al. Clinical Trial Design and Data Analysis Functions, Package clinfun, version 1.0.15 (Apr 2018)
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets documents generated under the project will be disseminated in accordance with Institut Curie policies.
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Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
Advanced Solid Tumors, Metastatic Solid Tumors
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced Solid Tumors, Recurrent Solid Tumors
RecruitingPhase 1
A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumor, Advanced Solid Tumor
Enrolling by invitationPhase 1
A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy
Metastatic Castration-resistant Prostate Cancer, Non-small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Paule SABLIN, MD, PhD principal investigator
Institut Curie
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dose escalation, first-in-human phase I clinical trial with an Expansion phase in people with Metastatic Solid Tumor Cancer, run by Institut Curie at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 80 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For Part 1 (Dose escalation) and Part 2 (Cohort 2), the primary endpoints are the rate of occurrence of DLT within cycle 1 (21 days) after initiation of the study treatment for both parts. (time frame: 21 days after study treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04733027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026; AzTrials last refreshed its copy on 4 Nov 2026.