NCT05759923

Brief Summary

The goal of this clinical trial is to learn if the OATD-02 administration (orally) in monotherapy is safe and has the pharmacodynamic potential to restore and enhance tumour responses to immunotherapy through increased arginine levels or intrinsic anti-tumour activity in participants with advanced metastatic colorectal cancer, ovarian cancer, renal cancer or pancreatic cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2023

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 24, 2025

Status Verified

July 1, 2024

Enrollment Period

2.8 years

First QC Date

February 9, 2023

Last Update Submit

February 20, 2025

Conditions

Advanced Ovarian CarcinomaAdvanced Renal Cell CarcinomaAdvanced Pancreatic CarcinomaAdvanced Colorectal CarcinomaMetastatic Pancreatic CarcinomaMetastatic Colorectal CarcinomaMetastatic Renal Cell CarcinomaMetastatic Ovarian Carcinoma

Keywords

solid tumorsrenal cancerovarian cancerpancreatic cancercolorectal cancer

Outcome Measures

Primary Outcomes (2)

  • Nature, frequency and severity of adverse events (AEs)

    6 months

  • Occurence of DLTs

    6 months

Secondary Outcomes (5)

  • PK parameters for OATD-02: CMax

    6 months

  • Anti-tumour activity parameters (Objective Response Rate (ORR), Duration of Response (DoR), PFS (Progression Free Survival) followed up to the End of Study Visit

    6 months

  • PK parameter: Tmax

    6 months

  • PK parameter Cmin

    6 months

  • PK parameter: AUCO-24

    6 months

Study Arms (1)

OATD-02

EXPERIMENTAL
Drug: OATD-02

Interventions

OATD-02DRUG

Boin Design Scheme will be applied for dose escalation. Dose will start with 2.5mg o.d., the desicion about dose escalations will be made based on the occurence of DLT

OATD-02

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Capable of understanding and complying with protocol requirements.
  • Male or female patient aged ≥18 years at Screening.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Histologically or cytologically confirmed advanced and/or metastatic colorectal cancer, renal cell cancer, or pancreatic cancer or recurrent serous ovarian cancer (platinum-resistant/ineligible to receive platinum-based chemotherapy), that either progressed or relapsed after all relevant standard of care cancer therapies (at least 1 line of systemic cancer therapy).
  • Written informed consent given by the patient before the initiation of any study procedures.

You may not qualify if:

  • Unable to take oral medications.
  • Clinically active central nervous system metastases and/or carcinomatous meningitis.
  • Major surgery within 30 days before the first IMP dose.
  • Pregnant or breastfeeding women.
  • Known allergy to excipients of the IMP.
  • Severe, uncontrolled systemic disease which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to participate in the study.
  • Participation in another clinical study within 4 weeks before the first IMP dose.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Site

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85796, Poland

RECRUITING

Site

Otwock, Masovian Voivodeship, 05-400, Poland

RECRUITING

SIte

Warsaw, Masovian Voivodeship, 01748, Poland

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsColorectal NeoplasmsCarcinoma, Renal CellOvarian NeoplasmsKidney Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesGonadal Disorders

Central Study Contacts

Clinical

CONTACT

0048225526724clinical@molecure.com

Molecure SA

CONTACT

0048225526724contact@molecure.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2023

First Posted

March 8, 2023

Study Start

January 26, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

February 24, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

PL(3)