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NCT Number: NCT05759923

First-in-human Phase I Study to Evaluate Safety, Tolerability and Antineoplastic Activity of OATD-02 in Patients with Selected Advanced And/or Metastatic Solid Tumours

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.

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Key information

Conditions

Advanced Ovarian Carcinoma Adenocarcinoma Adnexal Diseases Advanced Colorectal Carcinoma Advanced Pancreatic Carcinoma Advanced Renal Cell Carcinoma Carcinoma Carcinoma, Renal Cell Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Metastatic Colorectal Carcinoma Metastatic Ovarian Carcinoma Metastatic Pancreatic Carcinoma Metastatic Renal Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site, Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Loading trial locations.

About this study

In this study, subjects suitable for enrollment will be identified by the investigators involved in the study. These subjects will be identified through contact with these investigators and referred for enrollment per protocol. This protocol will include determining enrollment suitability based on inclusion and exclusion criteria.

Study scheme is based on Modified Bayesian Optimal Interval (BOIN) design.

The BOIN design works by partitioning the probability of toxicity into a set of intervals. This design makes dose-selection decisions determined by the interval in which the probability of toxicity for the current dose is believed to reside. BOIN seeks a dose with probability of toxicity close to some pre-specified target level.

Total number of patients will be 30 (plus 10 replacements if Dose Limiting Toxicity (DLT) is not evaluable).

Study treatment will be up to 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

OATD-02

Drug

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

Primary outcomes

  1. Nature, frequency and severity of adverse events (AEs)

    Time frame: 6 months

  2. Occurence of DLTs

    Time frame: 6 months

Secondary outcomes

  1. PK parameters for OATD-02: CMax

    Time frame: 6 months

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

    Time frame: 6 months

  3. PK parameter: Tmax

    Time frame: 6 months

  4. PK parameter Cmin

    Time frame: 6 months

  5. PK parameter: AUCO-24

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical

CONTACT

[email protected]

0048225526724

Molecure SA

CONTACT

[email protected]

0048225526724

Sponsors and collaborators

Lead sponsor

Molecure S.A.

Industry

Registry information

Official study title

An Open-label, Multicentre, Dose-escalation, First-in-human Phase I Study to Evaluate Safety, Tolerability and Antineoplastic Activity of OATD-02 in Patients with Selected Advanced And/or Metastatic Solid Tumours (colorectal Cancer, Ovarian Cancer, Pancreatic Cancer or Renal Cell Carcinoma)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2023
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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