Trials Sponsors Conditions Drugs Pricing

Conditions

Recurrent Extensive Stage Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (3)

Dose-limiting toxicities (DLT) of HTMC0435 combined with Temozolomide
Cycle 1 Day 1 to Cycle 1 Day 21
Adverse events (AE) of HTMC0435 combined with Temozolomide
Through study completion, an average of 6 months
Maximum tolerable dose (MTD) and RP2D of HTMC0435 combined with Temozolomide
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)
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)
Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - apparent clearance rate (CLz/F)
Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - maximum plasma concentrations (Cmax)
Cycle 1 Day 1 to Cycle 1 Day 9
Pharmacokinetic measures - time to reach Cmax (Tmax)
Cycle 1 Day 1 to Cycle 1 Day 9
+10 more secondary outcomes

Other Outcomes (2)

Changes in neuron-specific enolase (NSE) level from baseline
Through study completion, an average of 6 months
Changes in pro-gastrin-releasing peptide (PROGRP) level from baseline
Through study completion, an average of 6 months

Study Arms (2)

Phase 1b

EXPERIMENTAL

Escalating doses of HTMC0435 and Temozolomide

Drug: HTMC0435Drug: Temozolomide

Phase 2

EXPERIMENTAL

Recommended phase 2 dose (RP2D) of HTMC0435 and Temozolomide

Drug: HTMC0435Drug: Temozolomide

Interventions

HTMC0435Drug

Oral administration.

Phase 1bPhase 2

TemozolomideDrug

Oral administration.

Phase 1bPhase 2

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

Sponsors & Collaborators

Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Industrylead

Study Sites (3)

Zhejiang Cancer Hospital

Hangzhou, China

RECRUITING

Jiangsu Province Hospital of Chinese Medicine

Nanjing, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

MeSH Terms

Interventions

Temozolomide

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

Yun Fan, MD
Zhejiang Cancer Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Li

CONTACT

+86-21-64311017 clinical_trial@hllife.com.cn

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

February 15, 2023

Study Start

February 3, 2023

Actual (reported)

Primary Completion

August 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

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
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
+3 more criteria

HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (15)

Other Outcomes (2)

Study Arms (2)

Phase 1b

Phase 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (15)

Other Outcomes (2)

Study Arms (2)

Phase 1b

Phase 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations