Health TrialsbyHealthPanel

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

ConditionsAdvanced Ovarian CarcinomaAdvanced Renal Cell CarcinomaAdvanced Pancreatic CarcinomaAdvanced Colorectal CarcinomaMetastatic Pancreatic CarcinomaMetastatic Colorectal CarcinomaMetastatic Renal Cell CarcinomaMetastatic Ovarian Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMolecure S.A.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: OATD-02Experimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Molecure S.A.

Lead sponsor

Source ClinicalTrials.gov
Apply now