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Advanced Malignant TumorPhase 1NCT05015309

A Study to Investigate Safety and Tolerability of SH3765 Tablet in Patients With Advanced Malignant Tumor

A Phase 1 study testing SH3765 tablet in people with Advanced Malignant Tumor, run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective is to determine the safety and tolerability of SH3765 in subjects with advanced malignant tumor by determining the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Tumor
What is being tested?
SH3765 tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
Sep 2021to Sep 2024
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Age ≥ 18 years;
  • Patients must have a histologically or cytologically confirmed diagnosis of relapsed or refractory solid tumors or non-Hodgkin lymphomas (NHLs), with the following criteria specific to each tumor type:
  • For solid tumors: Patients must have advanced triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), adenoid cystic carcinoma (ACC), prostate cancer (PC), or head and neck squamous cell carcinoma (HNSCC). The malignancy must be relapsed or refractory after at least 1 prior line of anti-tumor therapy, and for which there are no available standard of care therapy or therapies known to provide clinical benefit; For NHLs: Patients must have mantle cell lymphoma (MCL), or non-germinal center B-cell-like (non-GCB) subtypes of diffuse large B-cell lymphoma (DLBCL) (both de novo and transformed non-GCB DLBCL are allowed). The malignancy must be relapsed or refractory after at least 2 prior lines of anti-tumor therapy, and for which there are no available standard of care therapy or therapies known to provide clinical benefit. The patients who require urgent cytoreductive therapy will be excluded, unless the patient has no remaining treatment choice with potential benefits.
  • Patients must provide archival tumor tissue, if available, from the most recent biopsy, or are able to undergo a tumor biopsy during screening;
  • At least one evaluable or measurable tumor lesion;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1;
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  • Life expectancy ≥3 months;
  • Adequate hematological and biological function, confirmed by the following laboratory values (Have not received blood transfusion or hematopoietic stimulating factor treatment within 14 days):APTT ≤1.0×ULN; Total bilirubin (TBIL) ≤1.5×ULN if no demonstrable liver lesion(s) (primary or metastases) or ≤3×ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver lesion(s); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN if no demonstrable liver lesion(s) (primary or metastases) or ≤5×ULN in the presence of liver lesion(s); Creatinine clearance ≥50mL/min (Calculated according to Cockcroft-Gault formula); Left ventricular ejection fraction (LVEF) ≥50%; QT interval corrected using Fridericia's method (QTcF)<470 msec; For advanced solid tumors patients: ANC ≥1.5×109/L, PLT ≥100×109/L, Hemoglobin (Hb) ≥90 g/L; For advanced non-Hodgkin lymphoma patients: ANC ≥ 1.0×109/L, PLT ≥ 80×109/L, Hemoglobin (Hb) ≥80 g/L;
  • Women of child bearing potential must agree to use a reliable form of contraception during the study treatment period and for at least 180 days following the last dose of study drug, and 3 days before treatment the pregnancy tests are negative. Men must agree to the use of male contraception during the study treatment period and for at least 180 days after the last dose of study drug;
  • Not using any other investigational drugs within 30 days before the study drugs administration;
  • Be informed of the trial before the start of the trial, and voluntarily sign the name and date on the informed consent form.

Who cannot join

  • Prior treatment with PRMT5 inhibitors;
  • Anticancer treatment including radiation therapy, chemotherapy, hormonal therapy, molecular targeted therapy, or immunotherapy within 3 weeks before the first dose of SH3765 (use of mitomycin or nitrosoureas within 6 weeks before the first dose; use of oral fluorouracil, such as tegafur and capecitabine, within 2 weeks before the first dose; use herbal medicine with anti-tumor indications within 2 weeks before the first dose);
  • Evidence of central nervous system (CNS) metastases;
  • Evidence of any severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, uncontrolled pleural effusion and ascites, uncontrolled diabetes, non-infectious pneumonia, or any other severe cardiovascular, respiratory, nervous and mental diseases;
  • Have severe cardiac disease:NYHA class ≥grade II heart failure; arrhythmia requiring medical treatment; myocardial infarction or unstable angina pectoris within 6 months; currently taking known QT extension drugs those who cannot stop the drug for at least 5 half-lives before starting the study drug treatment；
  • Patients who have active infection within 1 week before the first administration and need systematic anti-infection treatment;
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  • Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV). Patients with HBsAg positive but HBV-DNA negative, or with HCV antibody positive but HCV-RNA negative, or with HIV antibody positive but HIV-RNA negative and CD4+ T cell count normal will be inclusive;
  • Patients who received systemic glucocorticoids (prednisone >10 mg/ day or equivalent dose of the same drug) or other immunosuppressive therapy within 14 days before the first administration; except for topical, ocular, intra-articular, intranasal, and inhaled glucocorticoids; short-term use of glucocorticoids for prophylactic treatment (e.g., prevention of contrast agent allergy);
  • The patient is currently using (or cannot stop at least 1 week prior to the first administration of the study drug) a drug known to be a strong inhibitor or inducer of CYP3A4 and inhibitor of P-gp;
  • Patients who received granulocyte colony stimulating factor (G-CSF) or blood transfusion therapy within 7 days before the hematologic examination at the screening stage;
  • Autologous hematopoietic stem cell transplantation was performed within 90 days prior to the start of the study;
  • Previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation;
  • According to CTCAE 5.0, adverse reactions from previous anti-tumor therapy have not yet returned to ≤ grade 1 (except for toxicities which are judged by researchers to be safe, such as hair loss)；
  • Had major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first administration, or needed to undergo surgery during the trial period;
  • Uncontrolled nausea and vomiting, chronic gastrointestinal disease, inability to swallow pharmaceutical preparations, extensive enterectomy and possible impairment of adequate absorption of study drugs;
  • According to CTCAE 5.0, experiencing any CTCAE grade 3 or 4 gastrointestinal bleeding in the 3 months prior to enrollment;
  • Allergic to the similar drug or its excipients;
  • Lactating women;
  • The investigator determined that the patient should not participate in the study.

Trial locations and contacts

1 site in 1 country.

Ruihua Xu, PhD contact

86-20-87343468

xurh@sysucc.org.cn

China1 site

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ruihua Xu, PhD, 86-20-87343468, xurh@sysucc.org.cn

Other trials in China

About this study

Official title: A Phase I, Open-Label Study to Determine Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of SH3765 Tablet in Patients With Advanced Malignant Tumor

The primary objective is to determine the safety and tolerability of SH3765 in subjects with advanced malignant tumor by determining the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The second objective is to evaluate the PK profile and preliminary efficacy of SH3765 in subjects with advanced malignant tumor.

Read the detailed description

This is a Phase I, open-label, multicenter, multidose, two-part study to assess the safety, tolerability, PK and preliminary efficacy of SH3765, a protein arginine methyltransferase 5 (PRMT5) inhibitor, in subjects with advanced malignant tumor including but not limited to solid tumor and non-Hodgkin lymphoma.

Being tested
SH3765 tablet

What participants receive

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

  • SH3765 tabletDrug

    Starting dose 2.5mg, oral administered once daily. If tolerated subsequent cohorts will test increasing doses (5mg, 10mg, 15mg, 20mg, 25mg, 30mg) of SH3765.

Study groups in NCT05015309
Study groupRoleWhat they receive
SH3765 tabletExperimentalDaily oral administration of SH3765 tablet
Receives: Drug: SH3765 tablet

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    DLT is defined as an adverse event that meets protocol defined DLT criteria occurring from the first dose to the end of cycle 1 of multiple doses, except those unequivocally due to the underlying malignancy or an extraneous cause.

    Measured: Within the first 28 days of consecutive treatment

  2. Maximum tolerated dose (MTD)

    MTD was defined as the highest dose at which DLT occurred in less than one-third of subjects during the DLT observation period.

    Measured: Within the first 28 days of consecutive treatment

Secondary outcomes (10)

  1. Cmax

    Highest observed plasma concentration of SH3765

    Measured: 4 weeks

  2. Tmax

    Time of highest observed plasma concentration of SH3765

    Measured: 4 weeks

  3. T1/2

    Elimination half-life of SH3765

    Measured: 4 weeks

  4. Area Under the Curve (AUC)

    Area under the plasma concentration time curve of SH3765

    Measured: 4 weeks

  5. Mean Residence Time (MRT)

    The average residence time in body of SH3765

    Measured: 4 weeks

  6. Overall Response Rate (ORR)

    Measured: up to 12 months

  7. Progression-free survival (PFS)

    Measured: up to 12 months

  8. Disease control rates (DCR)

    Measured: up to 12 months

  9. Duration of response (DOR)

    Measured: up to 12 months

  10. Lymph node response rate (LNR)

    Measured: up to 12 months

Timeline

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

  1. First posted20 Aug 2021
  2. Study startSep 2021 (estimated)
  3. Primary completionMar 2023 (estimated)
  4. Study completionSep 2024 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05015309
Sponsor's protocol ID
SHC039-I-01
Status last verified
Aug 2021
First submitted
18 Aug 2021
Last updated
20 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SH3765 tablet in people with Advanced Malignant Tumor, run by Nanjing Sanhome 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 11 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: status not confirmed, as of the sponsor's last update on 20 Aug 2021. 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 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.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Ruihua Xu, PhD (86-20-87343468, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: Within the first 28 days of consecutive treatment). 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 NCT05015309.

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 20 Aug 2021.

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