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
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|ClinicalTrials.gov Identifier: NCT05759923|
Recruitment Status : Recruiting
First Posted : March 8, 2023
Last Update Posted : March 8, 2023
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|Condition or disease||Intervention/treatment||Phase|
|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||Drug: OATD-02||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||January 26, 2023|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||November 2024|
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
- Nature, frequency and severity of adverse events (AEs) [ Time Frame: 6 months ]
- Occurence of DLTs [ Time Frame: 6 months ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05759923
|Contact: Molecure SAfirstname.lastname@example.org|
|Bydgoszcz, Kujawsko-pomorskie, Poland, 85796|
|Otwock, Mazowieckie, Poland, 05-400|
|Warsaw, Mazowieckie, Poland, 01748|
|Responsible Party:||Molecure S.A.|
|Other Study ID Numbers:||
|First Posted:||March 8, 2023 Key Record Dates|
|Last Update Posted:||March 8, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Renal Cell
Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Endocrine Gland Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases