A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,938 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2024-02-21, after 2019-01-03 start.
Reason given by the sponsor: “business”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-02-21. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: to determinetransplantationpatientsquamous cellcarcinoma
Phrases that lowered it: immunogenicityimmunepatients whosolidsafety of -
Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 16.3% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 934 (raises risk) · Sponsor's track record
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Sponsor's past termination rate: 10.4% (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 74 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Number of arms: 6 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: not given (raises risk) · Who can join
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 6 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 934 (typical: 32)
- Sponsor's past termination rate
- 10.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 74 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 43 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 43 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- cemiplimab
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors NCT03192345 · started 2017 · scored riskier than 39% of active trials completed
- Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors NCT04717375 · started 2021 · scored riskier than 23% of active trials terminated
- A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201) NCT04913220 · started 2021 · scored riskier than 51% of active trials terminated
- First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours NCT04504669 · started 2020 · scored riskier than 14% of active trials completed
- A Study of Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers NCT01436565 · started 2011 · scored riskier than 39% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.