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Phase I Study of SPH1188-11 in NSCLC | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

Phase I Study of SPH1188-11 in NSCLC

Phase I, Open-label Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of SPH1188-11 Tablets for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).

NCT03231475•Shanghai Pharmaceuticals Holding Co., Ltd

View on ClinicalTrials.gov

Summary

This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.

Detailed Description

Phase I dose escalation study

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18-70years old, male or female.
•2. Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer(NSCLC),Stage IIIBorIV, previous treatment with 1st EGFR-TKI, and/or previous chemotherapy. Regardless of EGFR mutation status.
•3. At least one measurable disease according to RECIST 1.1.
•4. Life expectancy of at least 3 months.
•5. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
•6. Females should be using adequate contraceptive measures from the time of screening until 3 months after discontinuing study treatment, should not be breast feeding and must have a negative pregnancy test 7days prior to start of dosing. Males should be willing to use barrier contraception during the trial and 3 months after discontinuing study treatment.
•7. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.

Exclusion Criteria

•1. Treatment with an EGFR-TKI(eg, erlotinib, gefitinib, icotinib) within 7 days or approximately 5x half-life of study entry.
•2. Previous treatment with 2nd EGFR-TKI or 3rd EGFR-TKI(eg, afatinib, osimertinib).
•3. Any cytotoxic chemotherapy or anticancer drugs within 4 weeks of the first dose of study treatment.
•4. Major surgery(excluding placement of vascular access) within 4 weeks of the first dose of study treatment.
•5. Radiotherapy within 4 weeks of the first dose of study treatment.
•6. Patients currently receiving(or unable to stop use at least 1 week prior to receiving the first dose) medications or herbal supplements known to be potent inhibitors of CYP3A4/CYP2D6, and/or potent inducers of CYP3A4/CYP2D6.
•7. Laboratory values within 7 days of the first dose of study treatment:
•* Absolute neutrophil count\<1.5×10\^9/L
•* Platelet count \<100×10\^9/L
•* Haemoglobin\<90 g/L
+20 more criteria

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

July 21, 2017

Primary Completion Date

December 31, 2020

Completion Date

March 31, 2022

Last Updated

November 8, 2021

Conditions

NSCLC Stage IIIBNSCLC Stage IV

Interventions

SPH1188-11

DRUG

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

NCT06219317

NSCLC Stage IV

View study

RECRUITINGPHASE2

A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases

NCT06947694

NSCLC Stage IV Without EGFR/ALK Mutation

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RECRUITINGPHASE2

Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase I Study of SPH1188-11 in NSCLC

Inclusion Criteria

Exclusion Criteria

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases

Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy

Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung

1st Line Durvalumab in PS 2 NSCLC Patients

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