Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Advanced Solid Tumors
Model scores of the 29,894 trials active now.
Model score 9% 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 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2026-04-30, after 2023-03-29 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 2026-04-30. 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
-
Sponsor's past termination rate: 4.8% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: metastaticsubjects withradiationtransplantcancer
Phrases that lowered it: evaluate theopento evaluatelabelsolid -
Drug's FAERS reports with a death: 17.2% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 20 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 99.4% (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 4 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Design: sequential (lowers risk) · Design
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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
- 4 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 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
- 21 (typical: 32)
- Sponsor's past termination rate
- 4.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 20 (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
- 163 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 86 (typical: 412.5)
- Drug's FAERS reports marked serious
- 99.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- sintilimab
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
- Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors NCT06331559 · started 2024 · scored riskier than 24% of active trials terminated
- A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0237 in Adult Participants with Advanced Solid Tumors NCT05781360 · started 2023 · scored riskier than 11% of active trials terminated
- First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors NCT03758001 · started 2019 · scored riskier than 20% of active trials completed
- A Study of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas NCT04306224 · started 2020 · scored riskier than 19% of active trials completed
- Oral SAR245408 (XL147) and Oral MSC1936369B in Patients With Locally Advanced or Metastatic Solid Tumors NCT01357330 · started 2011 · scored riskier than 29% 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.