Oral NKT2152 for Kidney Cancer

Recruiting at 12 trial locations

Overseen By Sponsor Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: NiKang Therapeutics, Inc.

Must not be taking: Prednisone

Disqualifiers: Symptomatic brain metastases, Chronic lung condition, Significant cardiovascular disease, Active infection, others

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

Compensation: Varies

Number of Visits: Unknown

128 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing NKT2152, a new oral drug, in adults with a specific type of kidney cancer who have no other treatment options. It aims to find the safest dose and see if the drug can effectively fight the cancer.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received prior investigational or standard therapy within a certain time frame before starting the study drug. It's best to discuss your current medications with the trial team.

Eligibility Criteria

Adults (18+) with advanced clear cell renal cell carcinoma (ccRCC) that has worsened despite treatment can join. They must be able to swallow pills, have measurable disease, an ECOG status of 0-2, and a life expectancy over 3 months. Women must not be pregnant or breastfeeding and use birth control; men also need to agree to birth control measures.

Inclusion Criteria

My kidney cancer has spread, doesn't respond to treatment, and I've tried at least one therapy.

You must have a tumor that can be measured using specific guidelines for assessing tumor size.

I am not pregnant or breastfeeding and agree to use birth control or abstain from sex as required.

Exclusion Criteria

I have brain metastases but am stable and take ≤ 10 mg/day of prednisone.

Having one or more of the following conditions: A pulse oximetry reading less than 95% at screening, Any current requirement for intermittent or chronic supplemental oxygen, Any chronic lung condition which has required supplemental oxygen in the past, Evidence of impending airway compromise (such as endobronchial tumor, lymphangitic spread, significant extrinsic compression of major airway) per investigator, Ascites requiring drainage within 28 days prior to W1D1, History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other adequately treated Stage 1 or Stage 2 cancers currently in complete remission, or any other cancer that has been in complete remission for ≥ 2 years, Has failed to recover from the effects of prior anticancer therapy to baseline level or Grade 1 severity (except for alopecia) per NCI CTCAE; patients with treatable adverse effects such as hypothyroidism or hypertension may be enrolled if the adverse effect is controlled with treatment, Significant cardiovascular disease, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months prior to start of NKT2152 treatment; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy, symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; ≥ Grade 3 hypertension (diastolic blood pressure ≥ 100 mmHg or systolic blood pressure ≥160 mmHg) despite adequate use of anti-hypertensives; or history of congenital prolonged QT syndrome or repeated demonstration of a QTc interval > 480 ms; ejection fraction < 40%; clinically significant pericardial or pleural effusion in the opinion of the investigator, Has received prior investigational therapy or standard therapy within 5 half-lives of the agent or 4 weeks before the first administration of study drug, whichever is shorter, Has a bleeding diathesis or coagulopathy, Deep vein thrombosis (DVT)/pulmonary embolism are allowed as long as patient is not symptomatic and received 2 weeks or more of adequate anticoagulation, Has manifestations of malabsorption due to prior gastrointestinal (GI) surgery or GI disease, Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, Has had major surgery within 4 weeks before first study drug administration; the following procedures are not considered to be major surgeries: thoracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic or ultrasonographic procedures, mediastinoscopy, skin biopsy, incisional biopsy, image-guided biopsy for diagnostic purposes, and routine dental procedures, Has known human immunodeficiency virus (HIV), Has an active infection requiring systemic treatment, Is actively participating in another therapeutic clinical trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Escalation

Determine the maximum tolerated dose and/or recommended Phase 2 dose of NKT2152 as a single agent administered orally once daily

Approximately 1 year

Phase 2 Dose Expansion

Evaluate the safety, pharmacokinetics, and antitumor efficacy of NKT2152 in ccRCC patients, with patients randomized to one of two dosage levels

Approximately 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 1 year

Treatment Details

Interventions

• NKT2152

Trial Overview The trial is testing NKT2152, a HIF2α inhibitor for kidney cancer. The first phase determines the highest dose patients can take without serious side effects. The second phase checks how well it works in treating ccRCC.

Participant Groups

Group I: Phase 2 dose expansion Experimental Treatment 1 Intervention

Phase 2 dose expansion will evaluate the safety, pharmacokinetics and antitumor efficacy of NKT2152 as a single agent administered orally once daily in ccRCC patients. Patients will be randomized to one of two dosage levels being evaluated.

Group II: Phase 1 dose escalation Experimental Treatment 1 Intervention

Phase 1 is designed to determine the maximum tolerated dose and/or identify the recommended Phase 2 dose of NKT2152 as a single agent administered orally once daily in ccRCC patients

Who Is Running the Clinical Trial?

NiKang Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

1,000+