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Recurrent Extensive Stage Small Cell Lung CarcinomaPhase 1/2NCT05728619

HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer

A Phase 1/2 study testing HTMC0435 and Temozolomide in people with Recurrent Extensive Stage Small Cell Lung Carcinoma, run by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. at 3 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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 Phase 1b part of this clinical trial is to investigate the safety and pharmacokinetic (PK) characteristics of HTMC0435 tablets combined with temozolomide in patients with various advanced solid tumors (recurrent small cell lung cancer is preferred). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
HTMC0435 and Temozolomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
3 sitesChina
Study dates
3 Feb 2023to Oct 2024
Phase
Phase 1/2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, age ≥18 and <75 years old
  • Patients with histologically or cytologically confirmed recurrent or progressive extensive-stage SCLC, who have previously received at least first-line and no more than second-line treatments (HRR mutations are preferred)
  • [Only applicable to phase II part] At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0~1
  • Expected survival period ≥3 months
  • Prior to the enrollment, no serious hematopoietic abnormality, and generally normal function of heart, lung, liver and kidney
  • Understand and sign the informed consent form (ICF) voluntarily. Be willing and able to complete routine visits, treatment plans, laboratory examinations and other procedures.

Who cannot join

  • Prior treatment with any poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor
  • Prior temozolomide treatment interruption caused by toxicity
  • Received treatment with chemotherapy, radiation, biotherapy, endocrine therapy, immunotherapy, or other anti-tumor therapy ≤4 weeks prior to the first dose of HTMC0435
  • Any unrecovered AE of prior therapy ≥CTCAE 5.0 Grade 1 (except for toxicity that the investigators judged to have no safety risks, such as alopecia)
  • Currently suffering from interstitial lung disease ≥CTCAE Grade 2
  • Major surgery (excluding needle biopsy) within 4 weeks before the first dose of HTMC0435
Show all 18Show fewer
  • Past surgical history or severe gastrointestinal diseases that the investigator believes may affect the absorption, distribution or metabolism of the study drug, such as dysphagia, active gastric ulcer, ulcerative colitis, Crohn's disease, ileus, etc.
  • History of severe cardiovascular and cerebrovascular diseases
  • Received CYP3A4 potent inhibitors or inducers within 7 days before the first dose of HTMC0435 or need to use these medications during the study
  • Symptomatic brain metastases or meningeal metastases. Patients with these metastases who have received related treatment need to meet the following conditions before they can be enrolled: no radiographic evidence of progression ≥ 4 weeks after the end of treatment; completion of treatment ≥ 28 days before the first dose; no need for systemic corticosteroids treatment (>10 mg/day prednisone or equivalent dose) within 14 days before the first dose of HTMC0435
  • Active infectious diseases which need systemic anti-infection treatment
  • Hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) -DNA >1000 copies/mL or >200 IU/mL; hepatitis C virus antibody (HCV-Ab) positive
  • Human immunodeficiency virus antibody (HIV-Ab) positive
  • Previous or current diagnosis of myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML)
  • Women who are pregnant or breastfeeding; women/men who are planning to have a child; women/men who refuse to use medically approved contraceptive measures for contraception during the study treatment and within 6 months after the end of the study
  • Serious psychological or mental abnormalities that may affect compliance of patients in this study
  • Current alcohol or drug abusers
  • Judgment by the investigator that the patient is not suitable for this study due to other conditions

Trial locations and contacts

3 sites in 1 country.

Jun Li contact

+86-21-64311017

clinical_trial@hllife.com.cn

China3 sites, 3 recruiting

  • Zhejiang Cancer Hospital

    Hangzhou

    Recruiting

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Recruiting

Other trials in China

About this study

Official title: A Phase 1b/2, Dose-finding and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HTMC0435 With Temozolomide in Patients With Small Cell Lung Cancer

The Phase 1b part of this clinical trial is to investigate the safety and pharmacokinetic (PK) characteristics of HTMC0435 tablets combined with temozolomide in patients with various advanced solid tumors (recurrent small cell lung cancer is preferred). The Phase 2 part of the study is a multi-center, open-label, single-arm trial to investigate the preliminary efficacy of HTMC0435 and temozolomide in patients with recurrent small cell lung cancer (SCLC) at the recommended phase 2 dose.

Being tested
HTMC0435, Temozolomide

What participants receive

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

  • HTMC0435Drug

    Oral administration.

  • TemozolomideDrug

    Oral administration.

Study groups in NCT05728619
Study groupRoleWhat they receive
Phase 1bExperimentalEscalating doses of HTMC0435 and Temozolomide
Receives: Drug: HTMC0435; Drug: Temozolomide
Phase 2ExperimentalRecommended phase 2 dose (RP2D) of HTMC0435 and Temozolomide
Receives: Drug: HTMC0435; Drug: Temozolomide

What is being measured

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

  1. Dose-limiting toxicities (DLT) of HTMC0435 combined with Temozolomide

    Measured: Cycle 1 Day 1 to Cycle 1 Day 21

  2. Adverse events (AE) of HTMC0435 combined with Temozolomide

    Measured: Through study completion, an average of 6 months

  3. Maximum tolerable dose (MTD) and RP2D of HTMC0435 combined with Temozolomide

    Measured: Through study completion, an average of 6 months

Secondary outcomes (15)

  1. Pharmacokinetic measures - the area under the concentration-time curve from dosing (time 0) to time infinity (AUC 0-inf)

    Measured: Cycle 1 Day 1 to Cycle 1 Day 9

  2. Pharmacokinetic measures - the area under the concentration-time curve from dosing (time 0) to time t (AUC 0-t)

    Measured: Cycle 1 Day 1 to Cycle 1 Day 9

  3. Pharmacokinetic measures - apparent clearance rate (CLz/F)

    Measured: Cycle 1 Day 1 to Cycle 1 Day 9

  4. Pharmacokinetic measures - maximum plasma concentrations (Cmax)

    Measured: Cycle 1 Day 1 to Cycle 1 Day 9

  5. Pharmacokinetic measures - time to reach Cmax (Tmax)

    Measured: Cycle 1 Day 1 to Cycle 1 Day 9

  6. Pharmacokinetic measures - trough concentrations at steady state (Css, min)

    Measured: Cycle 1 Day 1 to Cycle 1 Day 9

  7. Pharmacokinetic measures - peak concentrations at steady state (Css, max)

    Measured: Cycle 1 Day 1 to Cycle 1 Day 9

  8. Pharmacokinetic measures - accumulation ratio (Rac)

    Measured: Cycle 1 Day 1 to Cycle 1 Day 9

  9. Pharmacokinetic measures - terminal plasma half-life (T1/2)

    Measured: Cycle 1 Day 1 to Cycle 1 Day 9

  10. Pharmacokinetic measures - apparent volume of distribution during terminal phase (Vz/F)

    Measured: Cycle 1 Day 1 to Cycle 1 Day 9

  11. Objective response rate (ORR) by RECIST v1.1

    Measured: Through study completion, an average of 6 months

  12. Disease control rate (DCR) by RECIST v1.1

    Measured: Through study completion, an average of 6 months

  13. Progression-free survival (PFS) by RECIST v1.1

    Measured: Through study completion, an average of 6 months

  14. Duration of response (DOR) by RECIST v1.1

    Measured: Through study completion, an average of 6 months

  15. Overall survival (OS) by RECIST v1.1

    Measured: Through study completion, an average of 6 months

Timeline

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

  1. First posted15 Feb 2023
  2. Study start3 Feb 2023
  3. Primary completionAug 2024 (estimated)
  4. Study completionOct 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05728619
Sponsor's protocol ID
HLND-01-TMZ-Ib/II-01
Status last verified
Jan 2023
First submitted
10 Jan 2023
Last updated
28 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HTMC0435 and Temozolomide in people with Recurrent Extensive Stage Small Cell Lung Carcinoma, run by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. at 3 sites 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 7 inclusion and 18 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Results are not available in the source record.

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

Contact Jun Li (+86-21-64311017, clinical_trial@hllife.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (DLT) of HTMC0435 combined with Temozolomide (time frame: Cycle 1 Day 1 to Cycle 1 Day 21). The study lists 3 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 NCT05728619.

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 28 Sep 2023.

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