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New drug cocktail targets Hard-to-Treat tumors

NCT ID NCT02264678

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This early-stage trial tests a new oral drug called ceralasertib, given alone or with other cancer treatments like chemotherapy or targeted drugs, in 354 adults with advanced solid tumors that no longer respond to standard care. The main goal is to check safety and find the best doses. Researchers are also looking at how the drug affects the body and whether it can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ceralasertib
What this could lead to
If successful, this could help determine safe doses of ceralasertib combinations for treating advanced solid tumors.
What could go wrong
This is an early Phase 1 trial focused on safety, not yet on effectiveness. Many drug combinations may not work or may cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

358 people

The number who actually took part.

Started

Oct 2014

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Principal Inclusion criteria: * Aged at least 18 * The presence of a solid malignant tumour that is not considered appropriate for further standard treatment * Module 2 Part B study expansions, and Module 3: patients must have a tumour at least 1 cm in size that can be measured using a CT or MRI scan * Module 2 Part B All (except B5): No previous treatment with PARP inhibitor. * Module 2 Part B1 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM deficient tumours * Module 2 Part B2 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM proficient tumours * Module 2 Part B3 Study expansion: Second or thrid line HER2 negative breast cancer * Module 2 Part B4 Study expansion: Second or third line triple negative breast cancer (TNBC) * Module 2 Part B5 Study expansion: BRCAm or RAD51C/Dm or PALB2m or HRD positive status ovarian cancer patient who are Platinum Sensitive Relapsed and have previously progressed on a licensed PARPi * Module 3: advanced recurrent or metastatic non-small cell lung cancer, or head and neck squamous cell carcinoma * Module 4: any advanced solid tumours except gastric, gastro-oesophageal, oesophageal or colorectal cancer with a small bowel resection * Module 4: Ability to comply with an overnight fast of at least 10 hours prior to dosing and 4 hours after dosing as mandated, and ability to eat a high fat meal as mandated * Module 5 All: Ovarian fallopian tube or primary peritonial cancer, previous treatment with PARP inhibitor, platinum-sensitive relapsed ovarian cancer * Module 5 Part B: known or suspected BRCA mutation, PALB2 mutation, RAD51C/D mutation or HRD positive status Principal exclusion criteria * A diagnosis of ataxia telangiectasia * Prior exposure to an ATR inhibitor * Bad reaction to ceralasertib * Module 2: Contra-indicated for treatment with olaparib * Module 3: Contra-indicated for treatment with durvalumab * Module 4: Mean resting corrected QT interval (QTc) \>470 msec or history of familial long QT syndrome. * Module 4: Patients with type I or type II diabetes * Module 5: Known hypersensitivity to PARP including AZD5305

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Conditions

The condition(s) this trial relates to.

breast cancer cancer fallopian tube cancer gastric adenocarcinoma head and neck squamous cell carcinoma Her2-receptor negative breast cancer non-small cell lung carcinoma ovarian cancer primary peritoneal carcinoma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adv solid malig - H&N SCC, ATM pro / def NSCLC, gastric, breast and ovarian cancer

Contacts and locations

Locations

  • Research Site

    Duarte, California, 91010, United States

  • Research Site

    Irvine, California, 92618, United States

  • Research Site

    Los Angeles, California, 90024, United States

  • Research Site

    Los Angeles, California, 90089, United States

  • Research Site

    Newport Beach, California, 92663, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    Bordeaux, 33076, France

  • Research Site

    Lyon, 69373, France

  • Research Site

    Saint-Herblain, 44805, France

  • Research Site

    Villejuif, 94805, France

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Seongnam-si, 13620, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Bristol, BS2 8ED, United Kingdom

  • Research Site

    Cambridge, CB2 0QQ, United Kingdom

  • Research Site

    Coventry, CV2 2DX, United Kingdom

  • Research Site

    London, SW3 6JJ, United Kingdom

  • Research Site

    London, W12 0HS, United Kingdom

  • Research Site

    London, W1G 6AD, United Kingdom

  • Research Site

    London, W1T 7HA, United Kingdom

  • Research Site

    Manchester, M20 4GJ, United Kingdom

  • Research Site

    Oxford, OX3 7LE, United Kingdom

  • Research Site

    Sutton, SM2 5PT, United Kingdom

  • Research Site

    Withington, M20 4BX, United Kingdom

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