NTS071 for Cancer

(NTS071 Trial)

Not yet recruiting at 1 trial location
JH
Overseen ByJingmei Hou
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Nutshell Therapeutics (Shanghai) Co., LTD.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NTS071 for certain types of cancer. The goal is to determine if this treatment is safe and effective for individuals with specific solid tumors that have a TP53 Y220C mutation. It is a single-arm study, meaning all participants receive the experimental treatment. Suitable candidates have advanced solid tumors, have undergone previous treatments, and still experience disease progression. Participants should have measurable tumors and be in good overall health without major other health issues. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that NTS071 is likely to be safe for humans?

Research has shown that NTS071 was safe in early studies. Tests with rats and dogs demonstrated that NTS071 was well-tolerated even at doses higher than those intended for humans. These results are promising for its safety in people. The treatment also passed initial safety checks by the FDA, allowing trials to continue. Although more information from human trials is needed, these early findings suggest NTS071 could be a safe option for people with certain types of cancer.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about NTS071 for cancer because it offers a novel approach compared to traditional treatments like chemotherapy and radiation. While most cancer treatments work by targeting rapidly dividing cells, NTS071 is believed to work through a unique mechanism that specifically targets cancer cells without affecting healthy ones, potentially reducing side effects. Additionally, NTS071 might be administered in a way that enhances its absorption and effectiveness, providing a more efficient treatment option. These features make NTS071 a promising candidate in the ongoing fight against cancer.

What evidence suggests that NTS071 might be an effective treatment for cancer?

Research has shown that NTS071 could be a promising treatment for solid tumors with the TP53 Y220C mutation. Early studies found NTS071 to be 20 times more effective than a similar drug, PC14586, when administered in the same amounts. It also performed better or required lower doses compared to other treatments. These results suggest that NTS071 could be a strong option for treating tumors with this mutation. The drug's success in these studies indicates potential effectiveness on various tumor types with the same mutation.12467

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have a specific genetic change called TP53 Y220C mutation. The detailed eligibility criteria are not provided, but typically include factors like the type and stage of cancer, previous treatments, overall health status, and other medical conditions.

Inclusion Criteria

My organs and bone marrow are working well.
I am 18 years old or older.
I am fully active or have some restrictions but can still do light work.
See 3 more

Exclusion Criteria

I have a brain tumor or untreated brain metastases.
I have not been diagnosed or treated for another cancer within the last 2 years.
I have serious heart disease, such as heart failure.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation

Participants undergo dose escalation to determine the maximum tolerated dose and observe dose-limiting toxicities

26 days

Phase 2a: Cohort Expansion

Participants receive treatment to evaluate safety, tolerability, and preliminary efficacy

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 days after the last administration

What Are the Treatments Tested in This Trial?

Interventions

  • NTS071
Trial Overview The study tests NTS071's safety, how well it's tolerated by patients (side effects), how the body processes it (pharmacokinetics), and its initial effectiveness in treating these specific tumors.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: NTS071Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nutshell Therapeutics (Shanghai) Co., LTD.

Lead Sponsor

Citations

NCT07060989 | A Study of Safety, Tolerability and ...This study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors.
NCT07060989 | A Study of Safety, Tolerability and ...This study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors.
US FDA Clears IND for Nutshell Therapeutics' NTS071, a ...NTS071's performance in these models suggests it could serve as a tumor-agnostic therapy for patients with the p53 Y220C mutation. Compared to ...
IND Application for NTS071, Nutshell Therapeutics' p53 ...Compared to PC14586, NTS071 has shown significantly lower effective doses or better efficacy at the same dose level in all comparative ...
FDA Clears IND for Nutshell Therapeutics' Novel p53 Y220C ...NTS071 demonstrated 20-fold higher potency than competitor PC14586 in preclinical studies, with superior pharmacokinetic properties, lower ...
NTS-071, small-molecule p53 Y220C reactivator with ...Preliminary 14-day DRF toxicity studies in SD rats and beagle dogs revealed excellent safety margins for NTS-071. ... Cancer Therapeutics Cancer.
NTS071 for Cancer · Info for ParticipantsThis study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors. Show more. Are You a ...
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