NXP800 for Advanced Cancers

Recruiting at 24 trial locations

Overseen by Susana Banerjee

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Nuvectis Pharma, Inc.

Must be taking: GnRH agonists, Bisphosphonates

Must not be taking: Nitrosoureas, Mitomycin-C

Disqualifiers: Pregnancy, Brain metastases, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests NXP800, a new drug, for safety and effectiveness in patients with advanced cancers, especially those with ARID1a-mutated ovarian carcinoma who haven't responded to other treatments. The goal is to find the safest dose and see if it can help control or reduce the cancer.

Will I have to stop taking my current medications?

You may need to stop certain medications before joining the trial. Specifically, you cannot have had radiotherapy, endocrine therapy, chemotherapy, or investigational agents within 28 days (or 42 days for some specific drugs) before starting the trial. However, you can continue taking bisphosphonates for bone disease or GnRH agonists if you have prostate cancer.

Research Team

Susana Banerjee

Principal Investigator

Institute of Cancer Research, Royal Marsden NHS Foundation Trust

Udai Banerji, Prof

Principal Investigator

Institute of Cancer Research, Royal Marsden Foundation Trust

Eligibility Criteria

Adults with advanced solid tumors without effective treatment options, or those inappropriate as per the investigator. Specifically for Part B: adults with ARID1a mutated ovarian cancers who've had certain prior treatments and have measurable disease progression. Excludes pregnant/lactating women, men unwilling to prevent pregnancy, and those with recent other treatments or ongoing severe side effects.

Inclusion Criteria

You have a tumor that can be measured using the RECIST Version 1.1 guidelines.

I am fully active or restricted in physically strenuous activity but can do light work.

My cancer worsened within 6 months after finishing platinum-based treatment.

Exclusion Criteria

I haven't had certain cancer treatments in the last 28-42 days.

I am a woman who could become pregnant, or am currently pregnant or breastfeeding.

I have severe side effects from past treatments.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part A: Dose escalation by cohort to identify the maximum tolerated dose of NXP800 in patients with advanced cancers

8-12 weeks

Weekly visits for dose adjustments and monitoring

Expansion

Part B: Administration of selected doses to patients with platinum-resistant, ARID1a-mutated ovarian carcinoma

12 weeks

Bi-weekly visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• NXP800 (Other)

Trial Overview NXP800 is being tested for safety at different doses/schedules in advanced cancer patients (Part A), and its preliminary efficacy in specific ovarian cancers with ARID1a mutation (Part B). The trial has two phases: dose escalation to assess safety and an expansion phase focusing on efficacy.

Participant Groups

Group I: Part B: Expansion in Ovarian Cancers Cohort 2 Experimental Treatment 1 Intervention

Subjects will be treated with NXP800 at 75 mg/day orally.

Group II: Part B: Expansion in Ovarian Cancers Cohort 1 Experimental Treatment 1 Intervention

Subjects will be treated with NXP800 at 50 mg/day orally.

Group III: Part A: Dose Escalation Experimental Treatment 1 Intervention

Escalating doses of NXP800 administered orally once or twice daily.

Who Is Running the Clinical Trial?

Nuvectis Pharma, Inc.

Lead Sponsor

Trials

2

Recruited

100+

The European Network for Gynaecological Oncological Trial groups (ENGOT)

Collaborator

Trials

2

Recruited

870+

European Network for Gynaecological Oncological Trial Groups

Collaborator

Trials

4

Recruited

2,900+

Gynecologic Oncology Group Foundation

Collaborator

Trials

3

Recruited

1,300+

GOG Foundation

Collaborator

Trials

48

Recruited

18,500+

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Trials

41

Recruited

19,200+