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Advanced Clear Cell Renal Cell CarcinomaPhase 1/2NCT07097935

Study of HS-10516 Combination Therapy in Patients With Advanced Renal Cell Carcinoma

A Phase 1/2 study testing HS-10516 + Lenvatinib in people with Advanced Clear Cell Renal Cell Carcinoma, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a multicenter, open-label, Phase Ib/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10516 in combination with lenvatinib in patients with advanced clear cell renal cell carcinoma (ccRCC) who have progressed after receiving at least one… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Clear Cell Renal Cell Carcinoma
What is being tested?
HS-10516 + Lenvatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteChina
Study dates
10 Jul 2025to 10 Jul 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women aged more than or equal to (≥) 18 years.
  • Histologically confirmed unresectable, locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) with disease progression during or after receiving ≥1 prior line of systemic therapy in the advanced setting.
  • Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required). Patients with only brain and/or bone lesions as target lesions will not be included.
  • ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks.
  • Estimated life expectancy greater than (>) 12 weeks.
  • Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 12 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.
  • Females must have the evidence of non-childbearing potential
  • Sign informed consent form.

Who cannot join

  • Prior or Current Treatments:
  • Previous or current use of hypoxia-inducible factor inhibitors.
  • Previous or current use of lenvatinib.
  • Use of Chinese herbal medicine with antitumor indications within 2 weeks prior to the first dose or requirement for such treatment during the study.
  • Administration of cytotoxic chemotherapy or other systemic antitumor therapies (e.g., endocrine therapy, molecular targeted therapy) within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose, or requirement for such treatments during the study.
  • Use of large-molecule antitumor drugs within 4 weeks prior to the first dose or requirement for such treatment during the study.
Show all 19Show fewer
  • Use of CYP2C19 strong inhibitors/inducers or narrow therapeutic index sensitive substrates within 7 days prior to the first dose, or requirement for continued use during the study.
  • Local radiotherapy (except brain radiotherapy; see Criterion 6) within 2 weeks prior to the first dose, or >30% bone marrow irradiation/large-field radiotherapy within 4 weeks prior to the first dose.
  • Major surgery (e.g., craniotomy, thoracotomy, laparotomy; Grade 3/4 per Chinese Medical Technical Clinical Application Regulations) within 4 weeks prior to the first dose.
  • Participation in other interventional clinical trials within 4 weeks prior to the first dose or within 5 half-lives of investigational drugs (whichever is longer).
  • Resting pulse oximetry <92% at screening.
  • Severe pulmonary dysfunction requiring intermittent/long-term oxygen therapy.
  • Unresolved Grade >1 toxicities from prior anti-tumor therapy (per CTCAE v5.0).
  • History of second primary malignancy.
  • Known or suspected active CNS metastases/leptomeningeal disease.
  • Inadequate bone marrow reserve or serious organ dysfunction.
  • Severe, uncontrolled, or active cardiovascular disease.
  • Severe or poorly controlled diabetes.
  • Severe or poorly controlled hypertension.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jun Guo contact

010-88196358

guoj307@126.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Jun Guo, 010-88196358, guoj307@126.com

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Study Evaluating the Safety, Efficacy, Tolerability, and Pharmacokinetics of HS-10516 Combination Therapy in Patients With Advanced Renal Cell Carcinoma

This is a multicenter, open-label, Phase Ib/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10516 in combination with lenvatinib in patients with advanced clear cell renal cell carcinoma (ccRCC) who have progressed after receiving at least one prior line of systemic therapy. The study comprises two distinct phases: a dose exploration phase and a proof-of-concept phase.

Read the detailed description

The study will commence with a dose exploration phase employing a safety lead-in approach. Treatment cycles are set at 28 days, with investigational product administration continuing until disease progression or meeting other treatment discontinuation criteria. Each dose level will enroll 3-6 participants for dose-limiting toxicity (DLT) assessment to evaluate the tolerability, safety, and PK/PD profiles of HS-10516 combined with lenvatinib. The Safety Review Committee (SRC) will determine subsequent dose levels for exploration through joint deliberation. If all predefined dose levels prove intolerable, the SRC may authorize exploration of lower dose levels. Additionally, PK expansion cohorts (up to 12 participants per cohort) may be implemented in suitable dose levels.

Following identification of safe dose levels in the exploration phase, 1-2 dose cohorts will advance to the proof-of-concept phase, with each cohort enrolling up to 40 participants to further assess therapeutic efficacy and safety.

Being tested
HS-10516 + Lenvatinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-10516 + LenvatinibDrug

    Administered orally.

Study groups in NCT07097935
Study groupRoleWhat they receive
Phase Ib (Dose exploration phase) Phase II (Proof-of-concept phase)ExperimentalTreatment cycles are set at 28 days, with investigational product administration continuing until disease progression or meeting other treatment discontinuation criteria.
Receives: Drug: HS-10516 + Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ib: MTD or RP2D

    MTD or RP2D was determined by number of participants with DLT in dose levels. A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0).

    Measured: Up to 3 months

  2. Phase II: Objective Response Rate (ORR)

    The percentage of patients who have achieved complete response and partial response, according to response evaluation criteria in solid tumors (RECIST) 1.1 by investigator's assessment.

    Measured: Up to 12 months.

Secondary outcomes (8)

  1. Incidence and severity of treatment-emergent adverse events

    Incidence of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: Up to 36 months.

  2. Disease control rate (DCR)

    The percentage of patients who have achieved complete response, partial response, and stable disease, according to response evaluation criteria in solid tumors (RECIST) 1.1 by investigator's assessment.

    Measured: Up to 24 months.

  3. Duration of response (DoR)

    The time from complete or partial response to disease progression or death, according to response evaluation criteria in solid tumors (RECIST) 1.1 by investigator's assessment.

    Measured: Up to 24 months.

  4. Progression-free survival (PFS)

    Progression free survival is defined as the duration of time from study entry to time of progression, death, or is censored at date of last disease assessment.

    Measured: Up to 24 months.

  5. Overall survival (OS)

    Overall survival is defined as the duration of time from study entry to death or the date of last contact.

    Measured: Up to 3 years.

  6. Maximum plasma concentration (Cmax)

    Cmax is defined as maximum observed serum concentration obtained directly from the observed concentration-time data.

    Measured: Up to 24 months.

  7. Time of maximum concentration (Tmax)

    Tmax is defined as the time required for a drug to reach peak concentration in plasma.

    Measured: Up to 24 months.

  8. AUC0-t

    Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration.

    Measured: Up to 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2025
  2. Study start10 Jul 2025
  3. Primary completion10 Jul 2027 (estimated)
  4. Study completion10 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07097935
Sponsor's protocol ID
HS-10516-103
Status last verified
Jul 2025
First submitted
30 Jul 2025
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HS-10516 + Lenvatinib in people with Advanced Clear Cell Renal Cell Carcinoma, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jun Guo (010-88196358, guoj307@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib: MTD or RP2D (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07097935.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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