Phase 1 Lung Cancer Trial, Recruiting NCT07107490 Sponsor: Chugai Pharmaceutical Condition: Lung Cancer
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Phase 1 Lung Cancer Trial, Recruiting

NCT07107490
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are older than 18 years at the time of signing the consent form
  • People whose cancer-related physical functioning is rated at a 0 or 1 on a standard scale used by doctors (meaning able to carry out normal daily activities with little or no restriction)
  • People who have been diagnosed with extensive stage small cell lung cancer confirmed through a tissue sample analysis
  • People whose cancer has come back after receiving at least one prior cancer treatment given throughout the body (such as chemotherapy)
  • People who have tumor tissue samples available — either stored from a previous biopsy or from a new biopsy
  • People whose cancer can be measured on scans according to a standard set of measurement rules used in cancer research
  • People whose blood counts and organ functions (such as liver and kidneys) are within acceptable levels as determined by the trial site

Who may not be able to join:

  • People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
  • People who have a history of a significant autoimmune disease (a condition where the immune system attacks the body)
  • People who test positive for HIV at the screening stage
  • People who have active hepatitis B or hepatitis C infection
  • People who have previously received certain targeted antibody treatments, specifically those directed at CD137, CD3, or DLL3 (confirm with trial site if unsure whether a past treatment falls into these categories)
  • People who have received any cancer treatment — including hormone therapy or radiation — within the 21 days before the first dose of the study drug
  • People who have previously experienced a severe (grade 4) immune-related side effect from certain immunotherapy drugs that target PD-L1, PD-1, or CTLA-4
  • People who had to stop a prior immunotherapy drug due to a serious (grade 3) immune-related side effect, or who experienced such a side effect within 6 months before the first dose of the study drug
  • People who received a live vaccine within the 4 weeks before the first dose of the study drug
  • People who have a history of cancer that started in the brain or spinal cord, brain or spinal cord spread that is causing symptoms or requires treatment, or spread to the lining around the brain
  • People who have a current or past significant brain or nervous system condition, such as stroke, epilepsy, inflammation of blood vessels in the brain, or a degenerative neurological disease

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Sponsor Chugai Pharmaceutical Co.Ltd, clinical-trials@chugai-pharm.co.jp

Phone: only use Email

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Chugai Pharmaceutical
Registry
ClinicalTrials.gov
Start date
8 October 2025
Est. completion
30 September 2028

Where this trial is recruiting

Hong Kong 🇯🇵 Japan 🇹🇼 Taiwan

Primary endpoints

All part : Adverse events of ALPS12[safety and tolerability]; Dose Escalation part : Dose-limiting toxicities (DLTs) and PK profile of ALPS12[safety and tolerability]; Dose Escalation part : Immunogenicity of ALPS12; Expansion part : Preliminary anti-tumor activity of ALPS12 when administered at selected dose(s) based on tumor assessment in patients with extensive stage SCLC

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov