NP-101 for Cancer

Overseen By Aung Naing, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

35 Participants Needed

Trial Summary

What is the purpose of this trial?

To evaluate the safety and preliminary efficacy of NP-101 in patients with solid tumors.

Research Team

Aung Naing, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults with advanced solid tumors that have worsened after treatment or lack standard options can join. They must be in good health otherwise, with proper organ/marrow function and a life expectancy over 3 months. Participants need to agree to contraception use and biopsies/blood tests. Those who've had recent treatments must wait before joining.

Inclusion Criteria

I have another cancer, but it won't affect this study's treatment.

My organs and bone marrow are functioning well.

Ability to comply with the study protocol, in the investigator's judgment

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug

I have an active hepatitis B or C infection.

My cancer has spread to my brain or its linings.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of NP-101 to determine safety and tolerability

12 weeks

Dose Expansion

Participants receive NP-101 at the determined safe dose to evaluate preliminary antitumor activity

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NP-101

Trial Overview The trial is testing NP-101's safety and early effectiveness on various solid tumors. It has two parts: first, finding the right dose (dose escalation), then seeing how well it works at that dose (dose expansion). Patients will take NP-101 orally.

Participant Groups

Group I: Dose Expansion Experimental Treatment 1 Intervention

Group II: Dose Escalation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Novatek Pharmaceuticals, Inc.

Collaborator