A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer
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| ClinicalTrials.gov Identifier: NCT05226507 |
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Recruitment Status :
Recruiting
First Posted : February 7, 2022
Last Update Posted : May 8, 2024
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Sponsor:
Nuvectis Pharma, Inc.
Collaborators:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
GOG Foundation
Information provided by (Responsible Party):
Nuvectis Pharma, Inc.
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Brief Summary:
The purpose of the dose escalation phase is to evaluate the safety profile of escalating doses and dose schedules of NXP800. In the expansion phase the preliminary efficacy in subjects with ARID1a mutated ovarian clear cell and ovarian endometrioid cancers will be estimated.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Solid Tumor Ovarian Cancer Ovarian Clear Cell Carcinoma Ovarian Clear Cell Tumor Ovarian Clear Cell Adenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Endometrioid Tumor ARID1A Gene Mutation | Drug: NXP800 | Phase 1 |
Part A of the study is a dose escalation by cohort study of NXP800 administered to patients with advanced cancers. The study will identify the maximum tolerated dose (MTD) and propose dose and dose schedules for future studies.
In Part B doses selected in Part A are administered to patients with platinum-resistant, ARID1a-mutated ovarian carcinoma.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 61 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | Part A dose escalation followed by Part B, expansion in ovarian cancers. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer |
| Actual Study Start Date : | December 31, 2021 |
| Estimated Primary Completion Date : | December 2024 |
| Estimated Study Completion Date : | June 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
MedlinePlus related topics:
Ovarian Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part A: Dose Escalation
Escalating doses of NXP800.
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Drug: NXP800
NXP800 is an anti-neoplastic, oral small molecule. |
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Experimental: Part B: Expansion in Ovarian Cancers Cohort 1
Subjects will be treated with NXP800 at 50 mg/day.
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Drug: NXP800
NXP800 is an anti-neoplastic, oral small molecule. |
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Experimental: Part B: Expansion in Ovarian Cancers Cohort 2
Subjects will be treated with NXP800 at 75 mg/day.
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Drug: NXP800
NXP800 is an anti-neoplastic, oral small molecule. |
Primary Outcome Measures :
- Part A: Number of patients with treatment related adverse events, clinical laboratory abnormalities, dose limiting toxicities [ Time Frame: Day 28 ]
- Part B: Estimates of disease response by RECIST v 1.1 [ Time Frame: Baseline to 30 days post last dose of NXP800 ]
- Part B: Number of patients with treatment related adverse events, and/or clinical laboratory abnormalities. [ Time Frame: Baseline to 30 days post last dose of NXP800 ]
Secondary Outcome Measures :
- Area under the concentration-time curve (AUC) of NXP800 [ Time Frame: First dose through Day 29 ]
- Maximum observed concentration (Cmax) of NXP800 [ Time Frame: First dose through Day 29 ]
- Time to peak concentration (Tmax) of NXP800 [ Time Frame: First dose through Day 29 ]
- Half-life (T1/2) of NXP800 [ Time Frame: First dose through Day 29 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Part B is enrolling ovarian cancer patients. |
| Accepts Healthy Volunteers: | No |
Criteria
Part A Inclusion Criteria:
- Provide written informed consent.
- 18 years old or older.
- Life expectancy of at least 12 weeks.
- Histologically- or cytologically-confirmed, advanced, metastatic, and/or progressive solid tumors for whom there is no authorized or effective therapy available, or for whom such therapies are considered inappropriate by the Investigator (in Part B, subjects with specific cancer types will be enrolled; Specific criteria will be introduced in a protocol amendment).
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Part A Exclusion Criteria:
- Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP800. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer.
- Ongoing toxic manifestations of previous treatments > Grade 2.
- Subjects with treated brain metastases are eligible if there is no evidence of progression for at least 28 days after central nervous system (CNS) directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) during the Screening period.
- Female subjects who can become pregnant (or are already pregnant or lactating).
- Male subjects with partners of childbearing potential (unless they agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence).
Part B Inclusion Criteria:
- Provide written informed consent.
- 18 years old or older.
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Subjects with the following ARID1a mutated, ovarian/fallopian tube/primary peritoneal cancer histologies (ARID1a mutation status determined by a DNA-based Next Generation Sequencing test):
- Clear cell ovarian carcinoma (≥ 50% clear cell carcinoma with no serous differentiation)
- Endometrioid ovarian carcinoma
- Subjects must have disease progression within 6 months (182 days) from completion of platinum-based therapy (6 months should be calculated from the date of the last administered dose of platinum therapy to the date of radiographic imaging showing progression)
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
- Subjects with a BRCA mutation must have received prior treatment with a PARP inhibitor.
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Subjects must have received at least 1 but not more than 3 prior systemic lines of anticancer therapy, including at least 1 line of therapy containing bevacizumab.
- Adjuvant + neoadjuvant are considered one line of therapy
- Maintenance therapy (i.e., bevacizumab, PARP inhibitors) will be considered as part of the preceeding line of therapy and are not counted independently.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subjects must have a sufficient archival Formalin-Fixed Paraffin-Embedded (FFPE) tissue specimen, or be willing to consent to a fresh tissue biopsy during the study.
Part B Exclusion Criteria:
- Subjects with disease that did not respond to, or has progressed during or within 4 weeks of the last dose of first-line platinum containing chemotherapy.
- Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP800.
- Ongoing toxic manifestations of previous treatments > Grade 2, with the exception of alopecia.
- Subjects with treated brain metastases are eligible if there is no evidence of progression for at least 12 weeks while off corticosteroids after central nervous system (CNS) directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) during the Screening period.
- Female subjects who can become pregnant (or are already pregnant or lactating).
Information from the National Library of Medicine
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): NCT05226507
Contacts
| Contact: Diane Marsolini | 201 627-8154 | dmarsolini@nuvectis.com | |
| Contact: Shay Shemesh, MSc | 201 614-3153 | sshemesh@nuvectis.com |
Locations
Show 18 study locations
Sponsors and Collaborators
Nuvectis Pharma, Inc.
European Network of Gynaecological Oncological Trial Groups (ENGOT)
GOG Foundation
Investigators
| Principal Investigator: | Udai Banerji, Prof | Institute of Cancer Research, Royal Marsden Foundation Trust | |
| Principal Investigator: | Susana Banerjee, Dr | Institute of Cancer Research, Royal Marsden NHS Foundation Trust |
| Responsible Party: | Nuvectis Pharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT05226507 |
| Other Study ID Numbers: |
NXP800-101 ENGOT-GYN5/NCRI/NXP800-101 ( Other Identifier: ENGOT ) GOG-3087 ( Other Identifier: GOG Foundation ) |
| First Posted: | February 7, 2022 Key Record Dates |
| Last Update Posted: | May 8, 2024 |
| Last Verified: | May 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Nuvectis Pharma, Inc.:
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Solid Tumor Carcinoma Neoplasms Adenocarcinoma ARID1a |
Additional relevant MeSH terms:
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Adenocarcinoma Ovarian Neoplasms Carcinoma, Ovarian Epithelial Carcinoma, Endometrioid Adenocarcinoma, Clear Cell Adenomyoepithelioma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Endometrial Neoplasms Uterine Neoplasms Neoplasms, Complex and Mixed |