Evidence map›Paper›PMID 39560862›Full record

ArticleTargeted oncology2025

Open-Label, Multicenter, Phase I Study to Assess Safety and Tolerability of Adavosertib Plus Durvalumab in Patients with Advanced Solid Tumors.

Manish R Patel, Gerald S Falchook, Judy S Wang, Esteban Rodrigo Imedio, Sanjeev Kumar, Kowser Miah, Ganesh M Mugundu, Suzanne F Jones, David R Spigel, Erika P Hamilton

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Targeted oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02617277 (A Phase I Study Assessing the Safety, Tolerability and Pharmacokinetics of AZD1775), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02617277 phase1completednot on this map

A Phase I Study Assessing the Safety, Tolerability and Pharmacokinetics of AZD1775 (Adavosertib) in Combination With MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumours

TypeinterventionalSponsorAstraZenecaRan2015 to 2026Enrolled56ConditionsAdvanced Solid TumoursArmsAZD1775, MEDI4736
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Advances in Systemic Therapy for Ovarian Cancer Over the Past Decade: A Clinical and Molecular Perspective.Medical science monitor : international medical journal of experimental and clinical research · 2025
    Review
  4. Review
  5. Targeting WEE1 Kinase for Breast Cancer Therapeutics: An Update.International journal of molecular sciences · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Manish R PatelFlorida Cancer Specialists, 600 N Cattlemen Rd, Suite #200, Sarasota, FL, 34232, USA. mpatel@flcancer.com.ORCID http://orcid.org/0000-0001-6836-2364
Gerald S FalchookSarah Cannon Research Institute at HealthONE, Denver, CO, USA.ORCID http://orcid.org/0000-0001-9165-2191
Judy S WangFlorida Cancer Specialists, 600 N Cattlemen Rd, Suite #200, Sarasota, FL, 34232, USA.
Esteban Rodrigo ImedioOncology R&D, AstraZeneca, Cambridge, UK.ORCID http://orcid.org/0000-0001-5666-666X
Sanjeev KumarOncology R&D, AstraZeneca, Cambridge, UK.
Kowser MiahClinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Boston, MA, USA.
Ganesh M MugunduClinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Boston, MA, USA.
Suzanne F JonesSarah Cannon Research Institute, Nashville, TN, USA.ORCID http://orcid.org/0000-0001-6881-8050
David R SpigelSarah Cannon Research Institute, Nashville, TN, USA.
Erika P HamiltonSarah Cannon Research Institute, Nashville, TN, USA.ORCID http://orcid.org/0000-0002-1911-0336

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdavosertib (AZD1775) is a small-molecule Wee1 inhibitor. Durvalumab is a PD-L1 inhibitor.

objectiveThe safety, tolerability, pharmacokinetics, and preliminary antitumor activity of adavosertib plus durvalumab were evaluated in patients with refractory solid tumors to define the maximum tolerated dose (MTD) and recommended phase II dose (RP2D). PATIENTS AND

methodsThis phase 1, non-randomized, open-label study determined MTD/RP2D using dose-escalation cohorts. Eligible patients had histologically confirmed tumors refractory to standard therapy or for which no standard of care existed.

resultsA total of 55 patients received adavosertib with durvalumab. Overall, 3/52 evaluable patients experienced dose-limiting toxicities (DLTs; two grade 3 nausea, one grade 3 diarrhea that did not respond to care within 48 h). The most frequent (in > 5% of patients) treatment-emergent grade ≥ 3 toxicities were fatigue, diarrhea, nausea, anemia, and abdominal pain. MTD for twice-daily (bid) adavosertib dosing was oral adavosertib 150 mg bid (3 days on/4 days off; treatment days 15-17 and 22-24 of a 28-day cycle) with intravenous durvalumab 1500 mg four times a week (Q4W), which was also the RP2D. MTD for once-daily (qd) adavosertib dosing was oral adavosertib 300 mg qd (5 days on/2 days off; treatment days 15-19 and 22-26 of a 28-day cycle) with intravenous durvalumab 1500 mg Q4W.

conclusionsThis study defined the MTD/RP2D of adavosertib plus durvalumab in patients with advanced solid tumors. The safety profile of adavosertib with durvalumab was consistent with the known safety data of each agent. Findings provide preliminary evidence of limited antitumor activity of adavosertib plus durvalumab.

trial registrationClinicalTrials.gov, NCT02617277 (registration: 30 November 2015).

Indexed as

Antibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsNeoplasmsPyrazolesPyrimidinonesAdultAgedAged, 80 and overFemaleHumansMaleMaximum Tolerated DoseMiddle AgedadavosertibAntibodies, MonoclonaldurvalumabPyrazolesPyrimidinones

Identifiers

PMID39560862
PMCPMC11762568

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.