Here is the design of a clinical trial:

Official Title: First in Human Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma

Included conditions:
- Castration-Resistant Prostatic Cancer

Study Armgroups:
- {'label': 'CC-1 therapy', 'type': 'EXPERIMENTAL', 'description': 'Infusion of CC-1 over 24 hours for 7 days with possible intra-patient dose-escalation. In case of clinical benefit, additional cycles with a total of up to six are possible.', 'interventionNames': ['Drug: CC-1, PSMAxCD3']}

Interventions:
- {'type': 'DRUG', 'name': 'CC-1, PSMAxCD3', 'description': 'Infusion of CC-1 over 24 hours for 7 days with possible intra-patient dose-escalation', 'armGroupLabels': ['CC-1 therapy']}

Primary Outcomes:
- {'measure': 'Incidence and severity of adverse events (AEs) (CTCAE V5.0) over 21 days (i.e. until end of first treatment cycle (day 28))', 'description': 'Grade 1 No interruption- No dose adjustment Grade 2 Interrupt until Grade 0/1- No dose adjustment Any Grade ≥ 3 Interrupt until Grade 0/1 Permanently stop, except that no DLT is caused; if the latter and if AE is resolved to Grade 0/1, resume with dose reduction by two dose levels', 'timeFrame': 'Each cycle is 28 days; Safety Assessment on day 1-9,15,22,28'}

Please estimate the sample size based on the assumption: 
Power of 80%, type one error of 5%, and a drop-out rate of 15%
Sample size calculation
        Depending on the occurrence of DLT in the dose escalation part, the patient number to define the MTD varies. A minimum number of 24 patients are treated, but potentially up to 86 patients may be included into the trial. Based on the broad range of dose levels to be tested (absolute doses of 28â1157âÂµg) and the employed intraindividual dose escalation (figure 2A), sample size may vary considerably dependent on CC-1-induced AEs. The dose escalation calculation is rule based on the titration design by Simon et al.26 Once the maximum tested dose is reached, additional six patients are treated to define MTD (figure 3). Thus, the sample size varies in the dose escalation part of the study between n=10 patients required for definition of the MTD in the minimal and n=72 patients in the maximum case. Subsequently, a dose expansion part with 14 patients is foreseen to gain more information about the MTD level and to better define the recommended phase II dose of CC-1. Based on the planning, in total 20 patients will be treated at the MTD level, 6 patients from the dose escalation phase and 14 patients of the expansion cohort. Thus, we will be able to estimate within a single-stage phase II design an objective response defined as PSA drop â¥50% estimating P0 the maximum response proportion of a poor drug of â¤30% of the patients, and P1 the minimum response proportion of a good drug of â¥60% with a power of 80% and a type one error of 5%. To this aim we will need n=17 evaluable patients assuming a drop-out rate of 15% (n=3).
        Estimation of sample size:
        Minimum: (4 escalation+6 highest dose)+14 expansion-cohort=24 patients
        Maximum: 12Ã6 escalation-cohort+14 expansion-cohort=86 patients