18 and older, any sex, with Locally Advanced Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Experienced Dose Limiting Toxicity (DLT) Confirmed by Safety Monitoring Committee (SMC)Primary· Time from first study intervention up to 19 weeks (including 5.5 weeks of treatment and 13.5 weeks of short term safety follow-up period)
DLT is defined as any of following treatment emergent adverse events (TEAEs) considered possibly related to study treatment by Investigator and/or Sponsor up to completion of assigned chemoradiotherapy treatment. DLT were based on SMC: Adverse drug reaction that, in the opinion of SMC, is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk; Any occurrence of drug-induced liver injury meeting the Hy's law criteria; Any Grade 3 toxicity excluding diarrhea, neutropenia lasting for ≤ 5 days, nausea \& vomiting, Grade 3 thrombocytopeni
Group
Value
95% CI
Peposertib 50 mg + RT + Capecitabine:
0
Peposertib 100 mg + RT + Capecitabine:
1
Peposertib 150 mg + RT + Capecitabine:
1
Peposertib 250 mg + RT + Capecitabine:
3
Number of Participants Wtih Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE) Version 5.0Secondary· Time from first study intervention up to long term safety follow-up period (Up to Month 35)
Adverse event (AE) is any untoward medical occurrence in participant administered pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless if it is considered related to medicinal product. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anom
Participants with TEAEs
Group
Value
95% CI
Peposertib 50 mg + RT + Capecitabine:
1
Peposertib 100 mg + RT + Capecitabine:
6
Peposertib 150 mg + RT + Capecitabine:
6
Peposertib 250 mg + RT + Capecitabine:
6
Participants with Treatment-Related TEAEs
Group
Value
95% CI
Peposertib 50 mg + RT + Capecitabine:
1
Peposertib 100 mg + RT + Capecitabine:
6
Peposertib 150 mg + RT + Capecitabine:
6
Peposertib 250 mg + RT + Capecitabine:
6
Number of Participants With Abnormalities [Grade Greater Than or Equals to (>=) 3] in Laboratory Test ValuesSecondary· Time from first study intervention up to long term safety follow-up period (Up to Month 35)
The laboratory measurements included hematology and biochemistry values were graded with National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 toxicity grades (where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening and Grade 5 = death). Number of participants with abnormalities Grade \>= 3 in laboratory test values were reported.
Group
Value
95% CI
Peposertib 50 mg + RT + Capecitabine:
1
Peposertib 100 mg + RT + Capecitabine:
6
Peposertib 150 mg + RT + Capecitabine:
6
Peposertib 250 mg + RT + Capecitabine:
6
Number of Participants With Markedly Abnormal Vital Sign MeasurementsSecondary· Time from first study intervention up to long term safety follow-up period (Up to Month 35)
Vital sign assessments included assessments of heart rate, diastolic blood pressure, systolic blood pressure, respiratory rate and temperature. Number of participants with markedly abnormal vital sign measurements were reported.
Group
Value
95% CI
Peposertib 50 mg + RT + Capecitabine:
0
Peposertib 100 mg + RT + Capecitabine:
0
Peposertib 150 mg + RT + Capecitabine:
0
Peposertib 250 mg + RT + Capecitabine:
0
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) FindingsSecondary· Time from first study intervention up to long term safety follow-up period (Up to Month 35)
Electrocardiograms (ECG) was obtained after the participant has been in a semi-supine position for at least 5 min. ECG parameters included heart rate, PQ/PR duration, QRS and QT duration, QT Interval. Clinical significance was determined by the investigator. Number of participants with clinically significant abnormalities in 12-lead ECG were reported.
Group
Value
95% CI
Peposertib 50 mg + RT + Capecitabine:
0
Peposertib 100 mg + RT + Capecitabine:
0
Peposertib 150 mg + RT + Capecitabine:
0
Peposertib 250 mg + RT + Capecitabine:
0
Percentage of Participants With Composite Pathological Complete Response (pCR)/ Clinical Complete Response (cCR)Secondary· At Week 15
pCR: It is defined as absence of viable tumor cells in the primary tumor and lymph nodes. Participants considered to have a pCR if they undergo surgery and no residual cancer is found on histological examination of removed specimen. cCR: Participants are considered to have a cCR if: 1) Absence of any residual tumor in primary site and draining lymph nodes on imaging with magnetic resonance imaging; 2) No visible lesion at endoscopy except a flat scar, telangiectasia, and/or whitening of mucosa; 3) Absence of any palpable tumor or irregularity on digital rectal examination (DRE) and endoscopic
Group
Value
95% CI
Peposertib 50 mg + RT + Capecitabine:
0.0
0.0 – 97.5
Peposertib 100 mg + RT + Capecitabine:
16.7
0.4 – 64.1
Peposertib 150 mg + RT + Capecitabine:
0.0
0.0 – 45.9
Peposertib 250 mg + RT + Capecitabine:
0.0
0.0 – 45.9
Disease-free SurvivalSecondary· Time from first study intervention up to approximately 35 months
Disease-free Survival time, defined as the time from first treatment day to the date of the first documentation of objective progressive disease or death due to any cause, whichever occurs first. Median disease-free survival time was estimated according to Kaplan-Meier method.
Group
Value
95% CI
Overall Participants
21.2
0.0 – 23.5
Percentage of Participants With Pathological Complete Response (pCR)Secondary· At Week 15
pCR is defined as the absence of viable tumor cells in the primary tumor and lymph nodes. Participants are considered to have a pCR if they undergo surgery and no residual cancer is found on histological examination of the removed specimen.
Group
Value
95% CI
Peposertib 50 mg + RT + Capecitabine:
0.0
0.0 – 97.5
Peposertib 100 mg + RT + Capecitabine:
0.0
0.0 – 45.9
Peposertib 150 mg + RT + Capecitabine:
0.0
0.0 – 45.9
Peposertib 250 mg + RT + Capecitabine:
0.0
0.0 – 45.9
Percentage of Participants With Clinical Complete Response (cCR)Secondary· At Week 15
cCR: It is defined as participants considered to have a cCR if: 1) Absence of any residual tumor in the primary site and draining lymph nodes on imaging with magnetic resonance; 2) No visible lesion at endoscopy except a flat scar, telangiectasia, and/or whitening of the mucosa; 3) Absence of any palpable tumor or irregularity on digital rectal examination (DRE) and endoscopic ultrasonography (EUS); 4) If a biopsy is taken, it must be negative.
Group
Value
95% CI
Peposertib 50 mg + RT + Capecitabine:
0.0
0.0 – 97.5
Peposertib 100 mg + RT + Capecitabine:
16.7
0.4 – 64.1
Peposertib 150 mg + RT + Capecitabine:
16.7
0.4 – 64.1
Peposertib 250 mg + RT + Capecitabine:
16.7
0.4 – 64.1
Time From Surgery to Local RecurrenceSecondary· Time from surgery up to 15 months
Time from surgery to local recurrence defined as time from day of surgery to the date of the first documentation of progression of disease, flagged as local recurrence. Median time from surgery to local recurrence was estimated according to Kaplan-Meier method.
Group
Value
95% CI
All Participants
NA
2.8 – 15.0
Time From Surgery to Distant MetastasisSecondary· Time from surgery up to 15 months
Time from surgery to distant metastasis defined as time from day of surgery to the date of the first documentation of progression of disease, flagged as distant metastasis. Median time from surgery to distant metastasis was estimated according to Kaplan-Meier method.
Group
Value
95% CI
All Participants
NA
2.8 – 15.0
Neoadjuvant Rectal (NAR) ScoreSecondary· At Week 15
The NAR formula includes the clinical tumor (cT) stage, pathologic tumor (pT), and node (pN) stage according to the tumor, node, metastasis classification system for colorectal cancers. The NAR formula is as follows:
\[5pN- 3 (cT- pT) + 12\]2 / 9.61
NAR score ranges from 0 to 100, whereas a score close to 100 is indicative of a poorer prognosis.
Group
Value
95% CI
Peposertib 100 mg + RT + Capecitabine:
9.4
± 7.95
Peposertib 150 mg + RT + Capecitabine:
13.8
± 1.69
Peposertib 250 mg + RT + Capecitabine:
21.2
± 12.11
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to long term follow-up period (approximately Month 35).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main purpose of the study was to define maximum tolerated dose (MTD), recommended Phase II dose (RP2D) safety and tolerability of Peposertib in combination with capecitabine and radiotherapy (RT).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc.
Last refreshed: 21 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03770689.