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.
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
- Conditions the study is for
- Recurrent Extensive Stage Small Cell Lung Carcinoma
- 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
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- 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.
China3 sites, 3 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou
- Recruiting
Jiangsu Province Hospital of Chinese Medicine
Nanjing
- Recruiting
Henan Cancer Hospital
Zhengzhou
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 group | Role | What they receive |
|---|---|---|
| Phase 1b | Experimental | Escalating doses of HTMC0435 and Temozolomide Receives: Drug: HTMC0435; Drug: Temozolomide |
| Phase 2 | Experimental | Recommended 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.
Dose-limiting toxicities (DLT) of HTMC0435 combined with Temozolomide
Measured: Cycle 1 Day 1 to Cycle 1 Day 21
Adverse events (AE) of HTMC0435 combined with Temozolomide
Measured: Through study completion, an average of 6 months
Maximum tolerable dose (MTD) and RP2D of HTMC0435 combined with Temozolomide
Measured: Through study completion, an average of 6 months
Secondary outcomes (15)
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
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
Pharmacokinetic measures - apparent clearance rate (CLz/F)
Measured: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - maximum plasma concentrations (Cmax)
Measured: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - time to reach Cmax (Tmax)
Measured: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - trough concentrations at steady state (Css, min)
Measured: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - peak concentrations at steady state (Css, max)
Measured: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - accumulation ratio (Rac)
Measured: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - terminal plasma half-life (T1/2)
Measured: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - apparent volume of distribution during terminal phase (Vz/F)
Measured: Cycle 1 Day 1 to Cycle 1 Day 9
Objective response rate (ORR) by RECIST v1.1
Measured: Through study completion, an average of 6 months
Disease control rate (DCR) by RECIST v1.1
Measured: Through study completion, an average of 6 months
Progression-free survival (PFS) by RECIST v1.1
Measured: Through study completion, an average of 6 months
Duration of response (DOR) by RECIST v1.1
Measured: Through study completion, an average of 6 months
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.
- First posted15 Feb 2023
- Study start3 Feb 2023
- Primary completionAug 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Extensive Stage Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yun Fan, MD, Principal investigator, Zhejiang Cancer Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05728619
- Acronym / sponsor ID
- HLND-01-TMZ-Ib/II-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1b | Experimental | Drug: HTMC0435, Drug: TemozolomideEscalating doses of HTMC0435 and Temozolomide |
| Phase 2 | Experimental | Drug: HTMC0435, Drug: TemozolomideRecommended phase 2 dose (RP2D) of HTMC0435 and Temozolomide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTMC0435Oral administration. | Drug | Phase 1b, Phase 2 |
| TemozolomideOral administration. | Drug | Phase 1b, Phase 2 |
Primary outcome
Dose-limiting toxicities (DLT) of HTMC0435 combined with Temozolomide
Time frame: Cycle 1 Day 1 to Cycle 1 Day 21
Adverse events (AE) of HTMC0435 combined with Temozolomide
Time frame: Through study completion, an average of 6 months
Maximum tolerable dose (MTD) and RP2D of HTMC0435 combined with Temozolomide
Time frame: Through study completion, an average of 6 months
15 secondary outcomes
Pharmacokinetic measures - the area under the concentration-time curve from dosing (time 0) to time infinity (AUC 0-inf)
Time frame: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - the area under the concentration-time curve from dosing (time 0) to time t (AUC 0-t)
Time frame: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - apparent clearance rate (CLz/F)
Time frame: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - maximum plasma concentrations (Cmax)
Time frame: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - time to reach Cmax (Tmax)
Time frame: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - trough concentrations at steady state (Css, min)
Time frame: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - peak concentrations at steady state (Css, max)
Time frame: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - accumulation ratio (Rac)
Time frame: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - terminal plasma half-life (T1/2)
Time frame: Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - apparent volume of distribution during terminal phase (Vz/F)
Time frame: Cycle 1 Day 1 to Cycle 1 Day 9
Objective response rate (ORR) by RECIST v1.1
Time frame: Through study completion, an average of 6 months
Disease control rate (DCR) by RECIST v1.1
Time frame: Through study completion, an average of 6 months
Progression-free survival (PFS) by RECIST v1.1
Time frame: Through study completion, an average of 6 months
Duration of response (DOR) by RECIST v1.1
Time frame: Through study completion, an average of 6 months
Overall survival (OS) by RECIST v1.1
Time frame: Through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun Fan, MD principal investigator
Zhejiang Cancer Hospital
3 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 6 Nov 2026.