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CYH33 + Olaparib for Ovarian Cancer

Phase 1
Recruiting
Research Sponsored by Haihe Biopharma Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with advanced solid tumor who have failed at least one line of prior systemic therapy or for whom standard therapy do not exist and meet the following eligibility for the corresponding part of the study:
Patients eligible for Part 2 dose expansion:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 38 months
Awards & highlights

Study Summary

This trial is testing a new combination drug to see if it is safe and effective in treating ovarian cancer that has progressed despite prior PARP inhibitor treatment.

Who is the study for?
This trial is for adults with advanced solid tumors, including specific types of ovarian, breast, prostate, and endometrial cancers. Participants must have certain gene mutations or resistance to PARP inhibitors and should not have received recent cancer treatment or have unresolved side effects from previous therapies.Check my eligibility
What is being tested?
The study tests CYH33 in combination with Olaparib on patients with advanced solid tumors to see if it's safe and effective. It aims to find the best dose that can be tolerated (MTD) and assess how well the drug combo works against tumor growth, especially in those resistant to PARP inhibitor treatments.See study design
What are the potential side effects?
While the trial will monitor safety closely, potential side effects may include typical reactions seen with cancer treatments such as nausea, fatigue, blood count changes. Specific risks related to CYH33 or Olaparib will be detailed during patient consent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a solid tumor that has advanced and standard treatments have not been effective, or there are no standard treatments available. You must have already received at least one type of treatment for your tumor.
Select...
Only certain patients are eligible for the second part of the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~38 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 38 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicities (DLT)
Tumor objective response rate (ORR)
Secondary outcome measures
Disease control rate (DCR)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Pharmacokinetic measures - CL/F
+5 more

Side effects data

From 2022 Phase 3 trial • 220 Patients • NCT03106987
39%
Nausea
24%
Asthenia
18%
Fatigue
18%
Anaemia
14%
Diarrhoea
12%
Constipation
11%
Abdominal pain
11%
Vomiting
9%
Dyspnoea
9%
Abdominal pain upper
8%
Headache
7%
Cough
5%
Neutropenia
5%
Leukopenia
5%
Dizziness
5%
Blood creatinine increased
5%
Dry mouth
5%
Muscle spasms
4%
Alanine aminotransferase increased
4%
Dysgeusia
3%
Aspartate aminotransferase increased
3%
Influenza
3%
Skin infection
3%
COVID-19 pneumonia
3%
Urinary tract infection
3%
Lymphopenia
3%
Thrombocytopenia
3%
Decreased appetite
3%
Insomnia
3%
Paraesthesia
3%
Hot flush
3%
Hypertension
3%
Dyspepsia
3%
Flatulence
3%
Dry skin
3%
Back pain
3%
Platelet count decreased
3%
Contusion
3%
Blood urea increased
1%
Neurotoxicity
1%
Rash maculo-papular
1%
Neuropathy peripheral
1%
Sluggishness
1%
Blood albumin decreased
1%
Fall
1%
Pleural infection
1%
Blood alkaline phosphatase increased
1%
Radius fracture
1%
Gastroenteritis cryptosporidial
1%
Genital herpes
1%
Gingivitis
1%
Hypermagnesaemia
1%
Peripheral sensory neuropathy
1%
Tinnitus
1%
Musculoskeletal pain
1%
Cystitis
1%
Pyrexia
1%
Bronchitis
1%
COVID-19
1%
Sinusitis
1%
Oesophageal squamous cell carcinoma
1%
Hypothyroidism
1%
Hypercholesterolaemia
1%
Hypokalaemia
1%
Hypomagnesaemia
1%
Hyponatraemia
1%
Bell's palsy
1%
Sciatica
1%
Syncope
1%
Dry eye
1%
Eye irritation
1%
Vertigo
1%
Palpitations
1%
Tachycardia
1%
Hypotension
1%
Dysphonia
1%
Rhinorrhoea
1%
Aphthous ulcer
1%
Gastrooesophageal reflux disease
1%
Oropharyngeal pain
1%
Odynophagia
1%
Stomatitis
1%
Alopecia
1%
Pruritus
1%
Rash
1%
Flank pain
1%
Hypercreatinaemia
1%
Muscular weakness
1%
Myalgia
1%
Osteoporosis
1%
Illness
1%
Mucosal inflammation
1%
Oedema peripheral
1%
Blood bilirubin increased
1%
Gamma-glutamyltransferase increased
1%
Lymphocyte count decreased
1%
Neutrophil count decreased
1%
Weight decreased
1%
Bone pain
1%
Hypocalcaemia
1%
Arthritis
1%
Polyneuropathy
1%
Tremor
1%
Chest pain
1%
Creatinine renal clearance decreased
1%
Rhinitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib (BRCA1/2 +ve)
Placebo (BRCA1/2 +ve)
Olaparib (BRCA1/2 -ve)
Placebo (BRCA1/2 -ve)

Trial Design

1Treatment groups
Experimental Treatment
Group I: CYH33 in Combination with OlaparibExperimental Treatment1 Intervention
CYH33 in Combination with Olaparib; 20 mg CYH33 QD in combination with olaparib 300 mg BID. Additional dose levels of CYH33 at20 and 30 mg QD and CYH33 at 40 mg QD in combination with olaparib 200 mg BID will be evaluated.

Find a Location

Who is running the clinical trial?

Haihe Biopharma Co., Ltd.Lead Sponsor
16 Previous Clinical Trials
1,772 Total Patients Enrolled
Joan Yu, MDStudy DirectorHaihe Biopharma

Media Library

CYH33 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04586335 — Phase 1
Breast Cancer Research Study Groups: CYH33 in Combination with Olaparib
Breast Cancer Clinical Trial 2023: CYH33 Highlights & Side Effects. Trial Name: NCT04586335 — Phase 1
CYH33 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04586335 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has CYH33 been studied previously in a research setting?

"Currently, CYH33 is the subject of 188 active clinical trials with 27 studies in their final phase. These medical research sites are primarily located in Houston, Texas but can also be found at 9250 other locations across the world."

Answered by AI

What medical conditions have been effectively treated with the drug CYH33?

"CYH33 is most commonly prescribed to address advance directives, but it may also be effective in treating malignant neoplasm of ovary, primary peritoneal cancer and various types of somatic hallucinations."

Answered by AI

Is this an unprecedented attempt to treat the condition?

"Since 2005, AstraZeneca has bankrolled research on the drug CYH33. After a trial involving 98 participants in its inaugural year of study, this compound was approved for Phase 1 clinical trials. Currently there are 188 active studies located across 1468 cities and 59 countries."

Answered by AI

Is the enrollment for this medical trial still open?

"According to the information found on clinicaltrials.gov, this trial is recruiting patients at present. The experiment was initially advertised on September 28th 2020 and had its most recent update released October 10th 2022."

Answered by AI

What risks do individuals run when using CYH33?

"CYH33's safety rating was assessed to be a 1 due to its Phase 1 status, which suggests only limited evidence for both efficacy and security."

Answered by AI

What are the intended outcomes for this scientific experiment?

"The primary outcome to be evaluated over a period of 12 months is the Tumor Objective Response Rate (ORR). Secondary outcomes include Disease Control Rate (DCR), Progression Free Survival, pharmacokinetic measures Vz/F and Cmax."

Answered by AI
~78 spots leftby Mar 2025