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New treatment option for Phase 1b
Official title A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK)
ClinicalTrials.gov ID: NCT07401875
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for phase 1b.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To find out if the combination of HC-7366 and nivolumab (with or without ipilimumab) can help to control ccRCC. The
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligibility Criteria
- Ability to understand and the willingness to sign a written informed consent document
- Male or female ≥ 18 years of age
- Confirmed diagnosis of clear cell RCC
- Stage IV metastatic RCC per American Joint Committee on Cancer
You likely can't join if
- 1\. For the Triplet Cohort (Nivo/Ipi/HC-7366):
- Prior systemic treatment including neoadjuvant or adjuvant therapy including an immune checkpoint inhibitor or TKI 2. For the Doublet Cohort...
- More than 3 prior lines of systemic therapy allowed
- Has received any type of small molecule kinase inhibitor (including investigational kinase inhibitor) ≤ 2 weeks before start of study drug or study...
- Major surgery requiring general anesthesia 4. ≤ 14 days before first dose of protocol-indicated treatment:
- Radiosurgery or radiotherapy
See the full eligibility criteria
Who can join
- Eligibility Criteria
- Ability to understand and the willingness to sign a written informed consent document
- Male or female ≥ 18 years of age
- Confirmed diagnosis of clear cell RCC
- Stage IV metastatic RCC per American Joint Committee on Cancer
- Triplet Cohort (IO/IO): No prior systemic therapy for advanced RCC or prior adjuvant therapy allowed.
- Doublet Cohort: Participant must have progressed on at least one PD1 based doublet regimen (IO/IO or IO/TKI). Prior adjuvant therapy is allowed and does count as one line of systemic therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 )
- At least one measurable lesion as defined by RECIST 1.1
- A tumor lesion situated in a previously irradiated area is considered a measurable/target lesion only if subsequent disease progression has been documented in the lesion
- Has pathology-confirmed RCC. Extra tissue should be submitted if available for correlatives. Formalin-fixed paraffin-embedded tissue blocks are preferred to slides. Details pertaining to tumor tissue submission can be...
- Willing and able to undergo bone and brain scans at baseline and continue to have scans performed if positive at screening.
- Adequate organ function within 28 days prior to first dose of protocol-indicated treatment, including:
- White blood cell (WBC) ≥ 2,000 /μL
- Absolute neutrophil count (ANC) ≥ 1,000/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin (Hgb) ≥ 9.0 g/dL in prior 4 weeks. Blood transfusions are allowed to achieve this.
- Serum creatinine ≤ upper limit of normal (ULN), or calculated creatinine clearance ≥ 30 mL/min (per the Cockcroft-Gault formula,)
- Total bilirubin ≤ ULN (except people with Gilbert Syndrome, who must have total bilirubin \< 3.0 mg/dL)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN
- Women must not be breastfeeding while taking the study drug and for up to five months after the last dose of study drug
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to receiving first dose of protocol-indicated treatment
- "Women of childbearing potential" (WOCBP) is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal
- Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological causes
- If menopausal status is considered for the purpose of evaluating childbearing potential, women \< 62 years of age must have a documented serum follicle stimulating hormone (FSH) level within laboratory reference range...
- Women of childbearing potential (WOCBP) must agree to follow instructions for acceptable contraception prior to the study and from the time of signing consent, for the duration of the study participation and for 23...
- The effects of HC-7366 on the developing human fetus are unknown. For this reason and because first-in-class, first-in-human agents as well as other therapeutic agents used in this trial are known to be teratogenic...
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy...
- Men not azoospermic who are sexually active with WOCBP must agree to follow instructions for acceptable contraception prior to the study and from the time of signing consent, for the duration of the study participation...
- Participant s with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Participant s with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- Participant s with previously treated brain metastases may be eligible provided they are radiologically (by MRI) and clinically stable (i.e., without evidence of disease progression) for at least 4 weeks (28 days) by...
- Participant s with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or how well it works assessment of the investigational regimen are eligible for this study
- Participant s with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
What rules you out
- 1\. For the Triplet Cohort (Nivo/Ipi/HC-7366):
- Prior systemic treatment including neoadjuvant or adjuvant therapy including an immune checkpoint inhibitor or TKI 2. For the Doublet Cohort (Nivo/HC-7366):
- More than 3 prior lines of systemic therapy allowed
- Has received any type of small molecule kinase inhibitor (including investigational kinase inhibitor) ≤ 2 weeks before start of study drug or study therapy 3. ≤ 28 days before first dose of protocol-indicated treatment:
- Major surgery requiring general anesthesia 4. ≤ 14 days before first dose of protocol-indicated treatment:
- Radiosurgery or radiotherapy
- Minor surgery. (Note: Placement of a vascular access device is not considered minor or major surgery)
- Active infection requiring systemic treatment 5. Known or suspected clinically significant active bleeding including active hemoptysis 6. Inability to swallow oral medication; or the presence of a poorly controlled...
- In the absence of active autoimmune disease: people are permitted the use of corticosteroids with minimal systemic absorption (e.g. topical, ocular, intraarticular, intranasal, and inhalational) ≤ 10 mg/day prednisone...
- people with type I diabetes mellitus; hypothyroidism only requiring hormone replacement; skin disorders such as vitiligo, psoriasis or alopecia not requiring systemic treatment; or conditions not expected by the...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.