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Advanced Solid TumorPhase 1/2NCT06132217

A Study of Simmitinib Plus SG001 in Advanced Solid Tumors

A Phase 1/2 study testing Simmitinib and SG001 in people with Advanced Solid Tumor, run by Shanghai Runshi Pharmaceutical Technology Co., Ltd at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is an open-label Phase I/II trial of simmitinib plus SG001 in patients with advanced solid tumors. Phase I will determine and confirm the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) for simmitinib in combination with SG001 in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Simmitinib and SG001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteChina
Study dates
30 Jan 2024to 30 Jan 2027
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have fully understood and voluntarily sign the ICF for this study;
  • Age of 18-75 years (inclusive);
  • Dose escalation phase: patients with histologically or cytologically confirmed inoperable or metastatic advanced solid tumors;
  • Dose expansion phase: patients who have failed standard treatment (PD or intolerable toxicity after treatment), have no available standard treatment.According to the previous data, the specific tumor cohort was expanded.
  • In the expansion phase, patients should agree to provide tissue specimens for detection of PD-L1 expression levels and/or MSI or dMMR status;
  • At least one measurable lesion according to RECIST 1.1;
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  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1;
  • Adequate organ function, defined as:
  • Neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 100× 10^9/L; Hemoglobin (Hb) ≥ 90 g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (≤ 5.0 × ULN for patients with liver metastases); Serum total bilirubin (TBIL) ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN; Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio(INR)≤1.5 × ULN; Thyroid Stimulating Hormone (TSH)≤ULN; Left ventricular ejection fraction (LVEF)≥50%; Male and female patients of childbearing age must agree to take effective contraceptive measures during treatment and within 6 months after the last dose of treatment.

Who cannot join

  • Patients who have previously received any anti-tumor therapy within 4 weeks prior to the first dose;
  • Urine protein ≥ ++ and 24 h urine protein > 1.0g at screening period;
  • Symptomatic central nervous system (CNS) metastases or meningeal metastases;
  • Patients who have previously received any live attenuated vaccine within 4 weeks before the first use of the study treatment or are expected to received any live attenuated vaccine during the study;
  • History of allergic reactions attributed to any monoclonal antibody, and uncontrolled history of allergic asthma;
  • Patients with other types of malignant tumors within 5 years prior to the screening, except for radically resected, non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ, or other carcinoma in situ;
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  • Patients with any active autoimmune disease requiring systemic therapy within 2 years prior to the first dose;
  • Patients with bleeding tendency; active bleeding or a history of heavy bleeding within the past 6 months;
  • Presence of any severe and/or uncontrolled disease before starting treatment;
  • Any active infection requiring antibiotics or hormones systemic treatment by intravenous infusion within 14 days prior to the first dose;
  • Dose expansion phase: Prior systemic therapy with immunosuppressants or immunoagonists targeting PD-1, PD-L1, CTLA-4, etc;
  • Dose expansion phase: Prior systemic therapy with Antiangiogenic drugs including Anlotinib, Afatinib , Lenvatinib, Sorafenib and Fruquintinib, etc;

Trial locations and contacts

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

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

China1 site

  • Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100000

    Lingying Wu, 86-010-87798996, wulingying@csco.org.cn

Other trials in China

About this study

Official title: A Phase I/II Study To Evaluate The Safety, Tolerability, Pharmacokinetic Profile And Preliminary Efficacy Of Simmitinib Plus SG001 in Patients With Advanced Solid Tumors

This is an open-label Phase I/II trial of simmitinib plus SG001 in patients with advanced solid tumors. Phase I will determine and confirm the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) for simmitinib in combination with SG001 in patients with advanced solid tumors. Phase 2 (Expansion) will evaluate the safety and efficacy of the combination in 3 cohorts at the RP2D from Phase I.

Being tested
Simmitinib, SG001

What participants receive

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

  • SimmitinibDrug

    Patients will oral administration according to study protocol until disease progression, death, unacceptable toxicity, loss of follow-up, withdrawal of consent or other conditions meet the end of treatment criteria.

  • SG001Drug

    Patients will receive intravenous infusion of SG001 according to study protocol until disease progression, unacceptable toxicity, meeting the suspension or termination criteria, or up to 24 months in patients without disease progression.

Study groups in NCT06132217
Study groupRoleWhat they receive
Dose Escalation Phase Cohort 1ExperimentalNot described
Receives: Drug: Simmitinib; Drug: SG001
Dose Escalation Phase Cohort 2ExperimentalNot described
Receives: Drug: Simmitinib; Drug: SG001
Dose Escalation Phase Cohort 3ExperimentalNot described
Receives: Drug: Simmitinib; Drug: SG001
Dose Expansion Phase Cohort AExperimentalNot described
Receives: Drug: Simmitinib; Drug: SG001
Dose Expansion Phase Cohort BExperimentalNot described
Receives: Drug: Simmitinib; Drug: SG001
Dose Expansion Phase Cohort CExperimentalNot described
Receives: Drug: Simmitinib; Drug: SG001

What is being measured

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

  1. Dose Escalation Phase: Dose Limited Toxicity (DLT)

    Measured: From Cycle 1 Day 1 to Cycle 1 Day 28(each cycle is 28 days)

  2. Dose Escalation Phase: Maximum Tolerated Dose (MTD)

    Measured: From Cycle 1 Day 1 to Cycle 1 Day 28(each cycle is 28 days)

  3. Dose Escalation Phase: Recommended Phase 2 Dose (RP2D)

    Measured: From Cycle 1 Day 1 to Cycle 1 Day 28(each cycle is 28 days)

  4. Dose Escalation Phase-Incidence rate of Adverse Event (AE).

    Measured: From first dose to 30 days post the last dose, with approximately 3 years

  5. Dose Expansion Phase - Objective Response Rate (ORR) evaluated by Independent Review Committee (IRC) or investigators in advanced solid tumor based on RECIST 1.1.

    Measured: Up to approximately 3 years.

Secondary outcomes (8)

  1. Plasma Concentration of simmitinib .

    Measured: Up to approximately 3 years.

  2. Plasma Concentration of SG001

    Measured: Up to approximately 3 years.

  3. Immunogenicity Assessments for Anti-drug Antibody

    Measured: Up to approximately 3 years.

  4. Dose Escalation Phase: ORR

    Measured: Up to approximately 3 years.

  5. Disease Control Rate (DCR)

    Measured: Up to approximately 3 years.

  6. Progression-free Survival (PFS)

    Measured: Up to approximately 3 years.

  7. Overall Survival (OS)

    Measured: Up to approximately 3 years.

  8. Duration of Objective Response (DOR)

    Measured: Up to Approximately 3 years.

Timeline

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

  1. First posted15 Nov 2023
  2. Study start30 Jan 2024 (estimated)
  3. Primary completion30 Jan 2027 (estimated)
  4. Study completion30 Jan 2027 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06132217
Sponsor's protocol ID
HA1818-003
Status last verified
Nov 2023
First submitted
9 Nov 2023
Last updated
15 Nov 2023
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 Simmitinib and SG001 in people with Advanced Solid Tumor, run by Shanghai Runshi Pharmaceutical Technology 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 9 inclusion and 12 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: opening soon, as of the sponsor's last update on 15 Nov 2023. 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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation Phase: Dose Limited Toxicity (DLT) (time frame: From Cycle 1 Day 1 to Cycle 1 Day 28(each cycle is 28 days)). The study lists 5 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 NCT06132217.

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 15 Nov 2023.

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