Oral NKT2152 for Kidney Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral medication, NKT2152, for individuals with kidney cancer, specifically clear cell renal cell carcinoma (ccRCC). The first phase aims to determine the safest dose, while the second phase evaluates the drug's effectiveness against the cancer. Suitable candidates have advanced or metastatic kidney cancer that has not responded to other treatments and continues to progress despite previous therapies. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that NKT2152 is likely to be safe for humans?

Previous studies showed that NKT2152 holds promise for treating kidney cancer. Its safety profile was similar to other drugs in its category. Some patients experienced expected side effects, such as anemia (a deficiency of healthy red blood cells) and hypoxia (low oxygen levels in the body), which are common with this type of treatment.

Since the trial is in its early stages, the main goal is to find the safest dose. Researchers are determining how much of the drug can be given without causing serious side effects. So far, the drug is being tested to find the best balance between effectiveness and safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for kidney cancer?

Researchers are excited about NKT2152 because it offers a new approach to treating kidney cancer, specifically clear cell renal cell carcinoma (ccRCC). Unlike standard treatments that often involve immune checkpoint inhibitors or targeted therapies like VEGF inhibitors, NKT2152 is taken orally and works by targeting a different pathway in the cancer cells. This unique mechanism could potentially provide an effective alternative for patients who do not respond well to existing options. The oral administration of NKT2152 also makes it more convenient for patients, which can improve their quality of life during treatment.

What evidence suggests that NKT2152 might be an effective treatment for kidney cancer?

Research has shown that NKT2152 holds promise for treating clear cell renal cell carcinoma (ccRCC), a type of kidney cancer. Early results indicate that about 20% of patients responded well to NKT2152. In this trial, participants will receive NKT2152 as a single agent, with the study evaluating two different dosage levels. The treatment has demonstrated a strong ability to fight tumors, especially in patients who have tried other treatments before. Specifically, patients taking NKT2152 had a median progression-free survival of about 7.4 months, meaning their cancer did not worsen during this time. This suggests that NKT2152 could be an effective option for those with advanced ccRCC. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. onclive.com onclive.com/view/dr-choueiri-on-initial-efficacy-data-with-nkt2152-in-pretreated-ccrcc

Dr Choueiri on Initial Efficacy Data With NKT2152 in ... Early data have shown a response rate of 20% with NTK2152, with on-target toxicities such as anemia and hypoxia—similar to those observed with ...

2. oncnursingnews.com oncnursingnews.com/view/nkt2152-shows-promising-efficacy-in-advanced-clear-cell-kidney-cancer

NKT2152 Shows Promising Efficacy in Advanced Clear ... NKT2152, a novel HIF2a inhibitor, demonstrates significant efficacy in patients with advanced clear cell renal cell carcinoma.

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)03302-7/fulltext

1690O NKT2152, a novel oral HIF-2α inhibitor, in ... NKT2152 demonstrated robust anti-tumor activity in heavily pretreated accRCC pts. The safety profile was consistent with this class of agent.

4. onclive.com onclive.com/view/nkt2152-generates-responses-in-heavily-pretreated-advanced-ccrcc

NKT2152 Generates Responses in Heavily Pretreated ... The median progression-free survival (PFS) was 7.392 months (95% CI, 3.745-12.58) in the overall population and 9.2 months in the dose- ...

5. urologytimes.com urologytimes.com/view/nkt2152-shows-strong-efficacy-in-advanced-clear-cell-renal-cell-carcinoma

NKT2152 shows strong efficacy in advanced clear cell ... Objective response rate in the 100 overall patient group was 20%, with progression-free survival of 7.4. In the part 1, with dose escalation, we ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05935748

NCT05935748 | Ph2 Study NKT2152 with Palbociclib & ... This is a Phase 2 open-label, multicenter, global study of NKT2152. This study is designed as two phases: a Lead-in phase and an Expansion phase.

7. urotoday.com urotoday.com/video-lectures/esmo-2024/video/4273-hif-2-alpha-inhibitor-nkt2152-shows-impact-in-renal-cell-carcinoma-eric-jonasch.html

HIF-2 Alpha Inhibitor NKT2152 Shows Impact in Renal ... The phase 1/2 study shows promising results in heavily pre-treated patients, with objective response rates around 25% and median progression- ...

8. trials.ohsu.edu trials.ohsu.edu/s/nkt2152-101-a-study-of-an-orally-administered-hif2-inhibitor-in-patients-with-advanced-clear-cell-renal-cell-carcinoma-319943/

NKT2152-101: A Study of An Orally Administered HIF2α ... The purpose of this study is to test how safe & effective a new investigational oral drug is for patients with a kidney cancer that is resistant to current ...