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RecruitingNCT05759923Updated Jul 31, 2026

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

A Phase 1 interventional study of OATD-02 in Advanced Ovarian Carcinoma, Advanced Renal Cell Carcinoma and Advanced Pancreatic Carcinoma, sponsored by Molecure S.A.. Recruiting at 3 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Molecure S.A. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Advanced Ovarian Carcinoma
  • Advanced Renal Cell Carcinoma
  • Advanced Pancreatic Carcinoma
  • Advanced Colorectal Carcinoma
  • Metastatic Pancreatic Carcinoma
  • Metastatic Colorectal Carcinoma
  • Metastatic Renal Cell Carcinoma
  • Metastatic Ovarian Carcinoma

Keywords

  • solid tumors
  • renal cancer
  • ovarian cancer
  • pancreatic cancer
  • colorectal cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Capable of understanding and complying with protocol requirements.
  2. Male or female patient aged ≥18 years at Screening.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  4. 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).
  5. Written informed consent given by the patient before the initiation of any study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Unable to take oral medications.
  2. Clinically active central nervous system metastases and/or carcinomatous meningitis.
  3. Major surgery within 30 days before the first IMP dose.
  4. Pregnant or breastfeeding women.
  5. Known allergy to excipients of the IMP.
  6. 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.
  7. Participation in another clinical study within 4 weeks before the first IMP dose.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    OATD-02

    Drug: OATD-02

Interventions

  • DrugOATD-02

    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

05

What researchers measure

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

06

Study locations

3 of 3 sites recruiting
  • Site
    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85796, Poland
    Recruiting
  • Site
    Otwock, Masovian Voivodeship 05-400, Poland
    Recruiting
  • SIte
    Warsaw, Masovian Voivodeship 01748, Poland
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05759923
Lead sponsor
Molecure S.A.
Responsible party
Sponsor
First posted
Mar 8, 2023
Start date
Jan 26, 2023
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Jul 31, 2026

Study contacts

Clinical
Contact
clinical@molecure.com
0048225526724
Molecure SA
Contact
contact@molecure.com
0048225526724

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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