Advanced Ovarian CarcinomaPhase 1NCT05759923
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 study testing OATD-02 in people with Advanced Ovarian Carcinoma and Advanced Renal Cell Carcinoma, run by Molecure S.A. at 3 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Ovarian Carcinoma, Advanced Renal Cell Carcinoma, Advanced Pancreatic Carcinoma
- What is being tested?
- OATD-02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesPoland
- Study dates
- 26 Jan 2023to 31 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland3 sites, 3 recruiting
- Recruiting
Site
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85796
- Recruiting
Site
Otwock, Masovian Voivodeship, 05-400
- Recruiting
SIte
Warsaw, Masovian Voivodeship, 01748
About this study
Official 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)
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.
- Conditions
- Advanced Ovarian Carcinoma, Advanced Renal Cell Carcinoma, Advanced Pancreatic Carcinoma, Advanced Colorectal Carcinoma, Metastatic Pancreatic Carcinoma, Metastatic Colorectal Carcinoma
- Being tested
- OATD-02
- Keywords
- solid tumors, renal cancer, ovarian cancer, pancreatic cancer, colorectal cancer
- Medical subject headings
- Pancreatic Neoplasms, Colorectal Neoplasms, Carcinoma, Renal Cell, Ovarian Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| OATD-02 | Experimental | Not described Receives: Drug: OATD-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature, frequency and severity of adverse events (AEs)
Measured: 6 months
Occurence of DLTs
Measured: 6 months
Secondary outcomes (5)
PK parameters for OATD-02: CMax
Measured: 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
Measured: 6 months
PK parameter: Tmax
Measured: 6 months
PK parameter Cmin
Measured: 6 months
PK parameter: AUCO-24
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start26 Jan 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Ovarian CarcinomaStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molecure S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759923
- Sponsor's protocol ID
- OATD-02-C-01
- Status last verified
- Jul 2026
- First submitted
- 9 Feb 2023
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05759923
- Acronym / sponsor ID
- OATD-02-C-01
- Conditions
- Advanced Ovarian Carcinoma, Advanced Renal Cell Carcinoma, Advanced Pancreatic Carcinoma, Advanced Colorectal Carcinoma, Metastatic Pancreatic Carcinoma, Metastatic Colorectal Carcinoma
- Keywords
- solid tumors, renal cancer, ovarian cancer, pancreatic cancer, colorectal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Molecure S.A.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 Mar 2023 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OATD-02 | Experimental | Drug: OATD-02 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| OATD-02Boin 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 | Drug | OATD-02 |
Primary outcome
Nature, frequency and severity of adverse events (AEs)
Time frame: 6 months
Occurence of DLTs
Time frame: 6 months
5 secondary outcomes
PK parameters for OATD-02: CMax
Time frame: 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
Time frame: 6 months
PK parameter: Tmax
Time frame: 6 months
PK parameter Cmin
Time frame: 6 months
PK parameter: AUCO-24
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OATD-02 in people with Advanced Ovarian Carcinoma and Advanced Renal Cell Carcinoma, run by Molecure S.A. at 3 sites in Poland.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 31 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 3 sites in Poland. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical (0048225526724, clinical@molecure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nature, frequency and severity of adverse events (AEs) (time frame: 6 months). 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?
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 31 Jul 2026.