Adults 18 to 130, any sex, with Urinary Bladder Neoplasms or Colorectal 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 With Treatment-emergent Adverse Events (TEAEs)Primary· From Day 1 up to 90 (±7 days) days after the last dose of AZD8853 (1 Year)
The safety and tolerability of AZD8853 in participants with selected advanced/metastatic solid tumors was assessed.
As per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, severity scale ranged from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
This outcome measure was assessed only for substudy 1 Part A.
Any AE
Group
Value
95% CI
AZD8853 300 mg
3
AZD8853 1000 mg
4
AZD8853 3000 mg
6
Any AE possibly related to treatment
Group
Value
95% CI
AZD8853 300 mg
1
AZD8853 1000 mg
0
AZD8853 3000 mg
2
Any serious adverse event (SAE)
Group
Value
95% CI
AZD8853 300 mg
1
AZD8853 1000 mg
3
AZD8853 3000 mg
2
Any SAE possibly related to treatment
Group
Value
95% CI
AZD8853 300 mg
0
AZD8853 1000 mg
0
AZD8853 3000 mg
0
Any SAE with outcome death
Group
Value
95% CI
AZD8853 300 mg
0
AZD8853 1000 mg
1
AZD8853 3000 mg
0
Any SAE with outcome death and possibly related to treatment
Group
Value
95% CI
AZD8853 300 mg
0
AZD8853 1000 mg
0
AZD8853 3000 mg
0
Any AE leading to discontinuation of IP
Group
Value
95% CI
AZD8853 300 mg
0
AZD8853 1000 mg
1
AZD8853 3000 mg
0
Any AE leading to discontinuation of IP and possibly related to treatment
Group
Value
95% CI
AZD8853 300 mg
0
AZD8853 1000 mg
0
AZD8853 3000 mg
0
Number of Participants With Dose Limiting Toxicity (DLT)Primary· From Cycle 1 Day 1 to end of Cycle 1 (21 days)
DLTs (in dose escalation Parts only) of AZD8853 in participants with selected advanced/metastatic solid tumors was assessed. The DLTs are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) as per NCI-CTCAE version 5.0 non-hematological toxicity or hematological toxicity. This outcome measure was assessed only for substudy 1 Part A.
Group
Value
95% CI
AZD8853 300 mg
0
AZD8853 1000 mg
0
AZD8853 3000 mg
0
Objective Response Rate (ORR)Secondary· First dose until progression of disease (PD) or last evaluable assessment in the absence of progression (1 Year)
ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR). This outcome measure was assessed only for substudy 1 Part A.
Group
Value
95% CI
AZD8853 300 mg
0
AZD8853 1000 mg
0
AZD8853 3000 mg
0
Disease Control Rate (DCR) at 15 WeeksSecondary· 15 weeks
Disease control was defined as a best overall response (BOR) of confirmed CR or PR or having stable disease (SD) (without subsequent cancer therapy) maintained for greater than or equal to (\>=) 14 weeks (study week 15) from first IP. Disease control rate at study week 15 weeks (DCR-15) was defined as the percentage of participants who had disease control at study week 15 weeks. This outcome measure was assessed only for substudy 1 Part A.
Group
Value
95% CI
AZD8853 300 mg
1
AZD8853 1000 mg
0
AZD8853 3000 mg
1
Progression Free Survival (PFS)Secondary· First dose until documented disease progression or study end (1 Year)
The PFS was defined as the time from the start of study intervention until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from study intervention or received another anti-cancer therapy prior to progression.
This outcome measure was assessed only for substudy 1 Part A.
Group
Value
95% CI
AZD8853 300 mg
1.31
1.18 – 3.38
AZD8853 1000 mg
1.23
1.15 – 3.15
AZD8853 3000 mg
1.25
0.95 – 3.29
Percentage Change From Baseline in Tumor SizeSecondary· Baseline (pre-treatment) up to Week 6 and Week 15
Tumor size was the sum of the longest diameters (or short axis measurements for lymph nodes) of the target lesions (TLs). Percentage change in tumor size was determined for participants with measurable disease at baseline. Baseline for Response evaluation criteria in solid tumors (RECIST) version 1.1 was defined as the last evaluable assessment prior to first IP dose. This outcome measure was assessed only for substudy 1 Part A.
Week 6
Group
Value
95% CI
AZD8853 300 mg
10.1
-0.9 – 16.7
AZD8853 1000 mg
10.9
-0.9 – 41.4
AZD8853 3000 mg
14.9
1.5 – 37.4
Week 15
Group
Value
95% CI
AZD8853 300 mg
46.5
46.5 – 46.5
AZD8853 1000 mg
5.7
5.7 – 5.7
AZD8853 3000 mg
70.0
13.2 – 126.7
Overall Survival (OS)Secondary· First dose until study end (1 Year)
Overall survival was defined as the time from the start of treatment until death due to any cause.
This outcome measure was assessed only for substudy 1 Part A.
Group
Value
95% CI
AZD8853 300 mg
4.47
2.92 – NA
AZD8853 1000 mg
5.45
2.30 – NA
AZD8853 3000 mg
NA
0.95 – NA
Percentage Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Levels From BaselineSecondary· Baseline (pre-treatment), Day 8 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3, 4, 5, 7 (each cycle is equal to 21 days)
Change in ctDNA is defined as the percentage change in ctDNA from baseline to each timepoint for the safety population. This outcome measure was assessed only for substudy 1 Part A.
Cycle 1 Day 8
Group
Value
95% CI
AZD8853 300 mg
74.3700
± 103.6200
AZD8853 1000 mg
30.2546
± 98.8909
AZD8853 3000 mg
10.7795
± 53.1457
Cycle 2 Day 1
Group
Value
95% CI
AZD8853 300 mg
92.1105
± 83.4783
AZD8853 1000 mg
32.1430
± 48.9060
AZD8853 3000 mg
20.7386
± 78.4507
Cycle 2 Day 8
Group
Value
95% CI
AZD8853 300 mg
101.0003
± 63.4941
AZD8853 1000 mg
84.2143
± 101.8080
AZD8853 3000 mg
116.3071
± 192.7165
Cycle 3 Day 1
Group
Value
95% CI
AZD8853 300 mg
64.9807
± 22.7578
AZD8853 1000 mg
131.5277
± 161.3495
AZD8853 3000 mg
26.9231
± NA
Cycle 4 Day 1
Group
Value
95% CI
AZD8853 300 mg
-8.3636
± NA
AZD8853 1000 mg
50.2904
± 54.8320
AZD8853 3000 mg
21.4744
± NA
Cycle 5 Day 1
Group
Value
95% CI
AZD8853 300 mg
64
± NA
AZD8853 1000 mg
50.4363
± NA
Cycle 7 Day 1
Group
Value
95% CI
AZD8853 300 mg
67.8182
± NA
Maximum Observed Concentration (Cmax) of AZD8853Secondary· 0 hour, 15 minutes, 2 hours, 6 hours, 24 hours, 168 hours and 336 hours post EOI of Cycle 1 (each cycle equals to 21 days)
The pharmacokinetic (PK) (Cmax) of AZD8853 in serum when administered in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.
Group
Value
95% CI
AZD8853 300 mg
76.70
± 3.439
AZD8853 1000 mg
339.5
± 96.74
AZD8853 3000 mg
1121
± 225.9
Area Under the Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of AZD8853Secondary· 0 hour, 15 minutes, 2 hours, 6 hours, 24 hours, 168 hours and 336 hours post EOI of Cycle 1 (each cycle equals to 21 days)
The PK (AUClast) of AZD8853 in serum when administered in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.
Group
Value
95% CI
AZD8853 300 mg
10080
± 1789
AZD8853 1000 mg
49210
± 12130
AZD8853 3000 mg
161100
± 43070
Partial Area Under the Plasma Concentration-time Curve From Time 0 to 504 Hours Post Dose (AUC[0-504 Hours]) of AZD8853Secondary· 0 hour, 15 minutes, 2 hours, 6 hours, 24 hours, 168 hours and 336 hours post EOI of Cycle 1 (each cycle equals to 21 days)
The PK (AUC\[t1-t2\]) of AZD8853 in serum when administered in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.
Group
Value
95% CI
AZD8853 300 mg
11870
± 2385
AZD8853 1000 mg
57230
± 14760
AZD8853 3000 mg
189400
± 56040
Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUCinf) of AZD8853Secondary· 0 hour, 15 minutes, 2 hours, 6 hours, 24 hours, 168 hours and 336 hours post EOI of Cycle 1 (each cycle equals to 21 days)
The PK (AUCinf) of AZD8853 in serum when administered in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.
Group
Value
95% CI
AZD8853 300 mg
14580
± 4136
AZD8853 1000 mg
67480
± 18490
AZD8853 3000 mg
223700
± 79270
Adverse events — posted to ClinicalTrials.gov
Time frame: From screening (Day -28 to Day -1) up to 90 (±7 days) days after the last dose of AZD8853 (1 Year)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
A Phase I/IIa First-in-human, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8853 in Participants with Selected Advanced/Metastatic Solid Tumours.
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 AstraZeneca
Last refreshed: 1 October 2024
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/NCT05397171.